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With this update, the FDA has authorized 950 AI/ML-enabled medical devices. </div> <p>The FDA is providing this list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area. The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the devices’ overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.</p> <p><strong>Contents of this list: </strong>This list contains publicly available information on AI/ML-enabled devices. The FDA compiled this list from the FDA’s publicly-facing information, including public-facing summaries and AI/ML specific product codes, as well as information in the <a href="#resources">publicly available resources cited below</a> (*) and in other publicly available materials published by the specific manufacturers.</p> <p>This list is not meant to be an exhaustive or comprehensive resource of medical devices that incorporate AI/ML. Rather, it is a list of medical devices that incorporate AI/ML across medical disciplines, primarily based on information provided in the summary descriptions of their marketing authorization document.</p> <p><strong>Updates to this list: </strong>The FDA updates this list on a periodic basis based on publicly available information. Send questions or feedback on this list to <a href="mailto:digitalhealth@fda.hhs.gov">digitalhealth@fda.hhs.gov</a>.</p> <hr> <h2>AI/ML-Enabled Medical Devices</h2> <p>This list contains publicly available information on AI/ML-enabled devices.</p> <p>Devices are listed in reverse chronological order by Date of Final Decision. To change the sort order, click the arrows in the column headings.</p> <p>Use the Submission Number link to display the approval, authorization, or clearance information for the device in the appropriate FDA database. The database page will include a link to the FDA's publicly available information.</p> <p class="text-align-center"><a class="btn btn-default" data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b4f8570f-89f7-4f7f-a001-4739a5f57fd8" href="/media/178541/download?attachment" title="AI ML Enabled Devices CSV Version">Download a CSV File</a>    <a class="btn btn-default" data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4e4595d8-58d8-43bd-aa88-975ec42704dc" href="/media/178540/download?attachment" title="AI ML Enabled Devices Excel Version">Download an Excel File</a>   <a class="btn btn-default" data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ad65e3c1-9d5d-4995-b4e8-eb6986f98a6f" href="/media/178565/download?attachment" title="AI ML Enabled Devices XML version">Save as XML File*</a></p> <p class="text-align-center"><em>*To save the XML file, right click and save the file to your computer and open in the appropriate program.</em></p> <div class="lcds-datatable lcds-datatable--ckeditor"> <table aria-readonly="true" class="table" data-column-defs="[{ "targets": 0, "type": "date" }]" data-order="[ 0, "desc" ]" data-page-length="50" data-paging="true" data-searching="true"> <thead> <tr> <th scope="col">Date of Final Decision</th> <th scope="col">Submission Number</th> <th scope="col">Device </th> <th scope="col">Company</th> <th scope="col">Panel (lead)</th> <th scope="col">Primary Product Code</th> </tr> </thead> <tbody> <tr> <td>06/25/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232111" target="_parent">K232111</a></td> <td>NeoBeat, NeoBeat Mini</td> <td>Laerdal Medical AS</td> <td>Cardiovascular</td> <td>MWI</td> </tr> <tr> <td>06/25/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240582" target="_parent">K240582</a></td> <td>VEA Align; spineEOS</td> <td>EOS imaging</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/21/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240465" target="_parent">K240465</a></td> <td>O-arm O2 Imaging System</td> <td>Medtronic Navigation, Inc</td> <td>Radiology</td> <td>OWB</td> </tr> <tr> <td>06/21/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233196" target="_parent">K233196</a></td> <td>Medihub Prostate</td> <td>JLK Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/21/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233253" target="_parent">K233253</a></td> <td>eCARTv5 Clinical Deterioration Suite ("eCART")</td> <td>AgileMD, Inc.</td> <td>Cardiovascular</td> <td>MWI</td> </tr> <tr> <td>06/21/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240631" target="_parent">K240631</a></td> <td>V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System</td> <td>Samsung Medison Co., Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>06/21/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233549" target="_parent">K233549</a></td> <td>Tempus ECG-AF</td> <td>Tempus AI, Inc.</td> <td>Cardiovascular</td> <td>SBQ</td> </tr> <tr> <td>06/20/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240642" target="_parent">K240642</a></td> <td>SMART Bun-Yo-Matic CT</td> <td>Disior Ltd</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/14/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232879" target="_parent">K232879</a></td> <td>Roche Digital Pathology Dx (VENTANA DP 200)</td> <td>Ventana Medical Systems, Inc.</td> <td>Pathology</td> <td>PSY</td> </tr> <tr> <td>06/14/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233955" target="_parent">K233955</a></td> <td>Clarius OB AI</td> <td>Clarius Mobile Health Corp.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>06/14/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241083" target="_parent">K241083</a></td> <td>SIS System</td> <td>Surgical Information Sciences, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/13/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233662" target="_parent">K233662</a></td> <td>Radiography 7300 C</td> <td>Philips Medical Systems DMC GmbH</td> <td>Radiology</td> <td>KPR</td> </tr> <tr> <td>06/13/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233925" target="_parent">K233925</a></td> <td>Relu Creator</td> <td>Relu BV</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/12/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240516" target="_parent">K240516</a></td> <td>RS85 Diagnostic Ultrasound System</td> <td>Samsung Medison Co., Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>06/07/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K234042" target="_parent">K234042</a></td> <td>EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)</td> <td>Ever Fortune.AI Co., Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/07/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241038" target="_parent">K241038</a></td> <td>Cardiac CT Function Software Application</td> <td>Circle Cardiovascular Imaging</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/07/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231010" target="_parent">K231010</a></td> <td>Corvair</td> <td>AliveCor, Inc.</td> <td>Cardiovascular</td> <td>MHX</td> </tr> <tr> <td>06/07/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232035" target="_parent">K232035</a></td> <td>Impala</td> <td>AliveCor, Inc.</td> <td>Cardiovascular</td> <td>DPS</td> </tr> <tr> <td>06/05/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240648" target="_parent">K240648</a></td> <td>Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)</td> <td>Radiant Innovation Inc.</td> <td>General Hospital</td> <td>FLL</td> </tr> <tr> <td>05/31/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240612" target="_parent">K240612</a></td> <td>CINA-VCF</td> <td>Avicenna.AI</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>05/24/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K234154" target="_parent">K234154</a></td> <td>uPMR 790</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>OUO</td> </tr> <tr> <td>05/24/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240769" target="_parent">K240769</a></td> <td>LVivo IQS</td> <td>DiA Imaging Analysis Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>05/23/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233108" target="_parent">K233108</a></td> <td>VinDr-Mammo</td> <td>VinBigData Joint Stock Company</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>05/23/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240294" target="_parent">K240294</a></td> <td>Syngo Carbon Enterprise Access (VA40A)</td> <td>Siemens Healthcare GmbH</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/21/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233543" target="_parent">K233543</a></td> <td>YSIO X.pree</td> <td>Siemens Medical Solutions</td> <td>Radiology</td> <td>KPR</td> </tr> <tr> <td>05/17/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233209" target="_parent">K233209</a></td> <td>uOmnispace.CT</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>05/16/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233625" target="_parent">K233625</a></td> <td>RAYDENT SW</td> <td>RAY Co., Ltd.</td> <td>Dental</td> <td>PNN</td> </tr> <tr> <td>05/15/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233247" target="_parent">K233247</a></td> <td>Heuron ICH</td> <td>Heuron Co., Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>05/15/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241112" target="_parent">K241112</a></td> <td>BriefCase-Quantification</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>05/10/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232410" target="_parent">K232410</a></td> <td>SmartChest</td> <td>Milvue</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>05/07/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232928" target="_parent">K232928</a></td> <td>DeepContour (V1.0)</td> <td>Wisdom Technologies., Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>05/07/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233864" target="_parent">K233864</a></td> <td>ASSURE Wearable ECG</td> <td>Kestra Medical Technologies, Inc.</td> <td>Cardiovascular</td> <td>MWJ</td> </tr> <tr> <td>05/03/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232491" target="_parent">K232491</a></td> <td>CT 5300</td> <td>Philips Healthcare (Suzhou) Co., Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>05/03/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233687" target="_parent">K233687</a></td> <td>ECHELON Synergy V10.0</td> <td>Fujifilm Healthcare Americas Corporation</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>05/03/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232416" target="_parent">K232416</a></td> <td>AUTION EYE AI-4510 Urine Particle Analysis System</td> <td>Arkray Inc.</td> <td>Hematology</td> <td>LKM</td> </tr> <tr> <td>04/30/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232923" target="_parent">K232923</a></td> <td>Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)</td> <td>Varian Medical Systems Inc.</td> <td>Radiology</td> <td>IYE</td> </tr> <tr> <td>04/29/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240062" target="_parent">K240062</a></td> <td>ARVIS® Shoulder</td> <td>Insight Medical Systems, Inc.</td> <td>Neurology</td> <td>OLO</td> </tr> <tr> <td>04/26/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232799" target="_parent">K232799</a></td> <td>syngo.via RT Image Suite</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>04/26/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240406" target="_parent">K240406</a></td> <td>Sonio Detect</td> <td>Sonio</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>04/26/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233673" target="_parent">K233673</a></td> <td>uMR Jupiter</td> <td>Shanghai United Imaging Healthcare Co., Ltd</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>04/25/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232331" target="_parent">K232331</a></td> <td>InVision Precision LVEF (LVEF)</td> <td>InVision Medical Technology Corporation</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>04/24/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240850" target="_parent">K240850</a></td> <td>EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems</td> <td>Philips Ultrasound LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>04/23/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240058" target="_parent">K240058</a></td> <td>AEYE-DS</td> <td>AEYE Health Inc.</td> <td>Ophthalmic</td> <td>PIB</td> </tr> <tr> <td>04/22/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233582" target="_parent">K233582</a></td> <td>Rapid</td> <td>iSchema View Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/22/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K234068" target="_parent">K234068</a></td> <td>ART-Plan (v.2.2.0)</td> <td>Therapanacea SAS</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>04/19/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240781" target="_parent">K240781</a></td> <td>SKOUT® system</td> <td>Iterative Scopes, Inc.</td> <td>Gastroenterology-Urology</td> <td>QNP</td> </tr> <tr> <td>04/17/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233186" target="_parent">K233186</a></td> <td>uOmnispace.MR</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>04/16/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232202" target="_parent">K232202</a></td> <td>Aperio GT 450 DX</td> <td>Leica Biosystems Imaging, Inc.</td> <td>Pathology</td> <td>PSY</td> </tr> <tr> <td>04/15/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240773" target="_parent">K240773</a></td> <td>VisAble.IO</td> <td>Techsomed</td> <td>Radiology</td> <td>QTZ</td> </tr> <tr> <td>04/12/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240238" target="_parent">K240238</a></td> <td>Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>04/11/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233698" target="_parent">K233698</a></td> <td>True Enhance DL</td> <td>GE Healthcare Japan Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>04/10/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240744" target="_parent">K240744</a></td> <td>uMR 680</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>04/09/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230023" target="_parent">DEN230023</a></td> <td>Rho</td> <td>16 Bit Inc</td> <td>Radiology</td> <td>SAO</td> </tr> <tr> <td>04/08/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240291" target="_parent">K240291</a></td> <td>EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM</td> <td>Ever Fortune.AI, Co., Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>04/05/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233249" target="_parent">K233249</a></td> <td>APPRAISE-HRI</td> <td>The Surgeon General, Department of the Army (TSG-DA)</td> <td>Cardiovascular</td> <td>SAR</td> </tr> <tr> <td>04/05/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233666" target="_parent">K233666</a></td> <td>CorVista System with PH Add-On</td> <td>Analytics for Life, Inc.</td> <td>Cardiovascular</td> <td>SAT</td> </tr> <tr> <td>04/04/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240172" target="_parent">K240172</a></td> <td>Preview Shoulder</td> <td>Genesis Software Innovations</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>04/03/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232899" target="_parent">K232899</a></td> <td>AI-Rad Companion Organs RT</td> <td>Siemens Medical Solutions U.S.A.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>04/03/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233618" target="_parent">K233618</a></td> <td>Oxevision Sleep Device</td> <td>Oxehealth Limited</td> <td>Neurology</td> <td>LEL</td> </tr> <tr> <td>04/02/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232835" target="_parent">K232835</a></td> <td>Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>04/01/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233676" target="_parent">K233676</a></td> <td>Us2.v2</td> <td>Eko.ai Pte. Ltd d/b/a Us2.ai</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>03/29/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233211" target="_parent">K233211</a></td> <td>AVIEW CAC</td> <td>Coreline Soft Co., Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>03/28/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233657" target="_parent">K233657</a></td> <td>NAEOTOM Alpha</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/28/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233409" target="_parent">K233409</a></td> <td>Eko Low Ejection Fraction Tool (ELEFT)</td> <td>Eko Health, Inc.</td> <td>Cardiovascular</td> <td>QXO</td> </tr> <tr> <td>03/26/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233650" target="_parent">K233650</a></td> <td>SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/22/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232322" target="_parent">K232322</a></td> <td>MAGNETOM Terra; MAGNETOM Terra.X</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>03/22/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232431" target="_parent">K232431</a></td> <td>syngo.CT Brain Hemorrhage</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>03/22/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240540" target="_parent">K240540</a></td> <td>uMR Omega</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>03/21/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233753" target="_parent">K233753</a></td> <td>AI-Rad Companion (Pulmonary)</td> <td>Siemens Healthcare GmbH</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/20/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K234047" target="_parent">K234047</a></td> <td>Automatic Registration</td> <td>Brainlab AG</td> <td>Orthopedic</td> <td>OLO</td> </tr> <tr> <td>03/15/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233342" target="_parent">K233342</a></td> <td>CINA-ASPECTS</td> <td>Avicenna.AI</td> <td>Radiology</td> <td>POK</td> </tr> <tr> <td>03/13/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233968" target="_parent">K233968</a></td> <td>CINA-iPE</td> <td>Avicenna.AI</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>03/11/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232140" target="_parent">K232140</a></td> <td>OTS Hip</td> <td>Ortoma AB</td> <td>Orthopedic</td> <td>OLO</td> </tr> <tr> <td>03/08/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233438" target="_parent">K233438</a></td> <td>SleepStageML</td> <td>Beacon Biosignals, Inc.</td> <td>Neurology</td> <td>OLZ</td> </tr> <tr> <td>03/06/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231677" target="_parent">K231677</a></td> <td>EdgeFlow UH10</td> <td>Edgecare Inc.</td> <td>Radiology</td> <td>IYO</td> </tr> <tr> <td>03/04/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233738" target="_parent">K233738</a></td> <td>Overjet Caries Assist-Pediatric</td> <td>Overjet, Inc</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>03/01/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233030" target="_parent">K233030</a></td> <td>BoneMRI</td> <td>MRIguidance B.V</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>03/01/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231690" target="_parent">K231690</a></td> <td>iCAS-LV</td> <td>HighRAD Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>02/29/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231683" target="_parent">K231683</a></td> <td>inHEART Models</td> <td>inHEART, SAS</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>02/29/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232765" target="_parent">K232765</a></td> <td>MAGNETOM Cima.X Fit</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>02/28/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232613" target="_parent">K232613</a></td> <td>CT Cardiomegaly</td> <td>Innolitics, LLC</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>02/23/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233590" target="_parent">K233590</a></td> <td>Overjet Charting Assist</td> <td>Overjet, Inc</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>02/22/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233749" target="_parent">K233749</a></td> <td>Revolution Ascend Sliding</td> <td>GE Hangwei Medical Systems Co., Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>02/21/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232148" target="_parent">K232148</a></td> <td>X-Guide Surgical Navigation System</td> <td>X-Nav Technologies, LLC</td> <td>Dental</td> <td>QRY</td> </tr> <tr> <td>02/15/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232915" target="_parent">K232915</a></td> <td>EpiMonitor</td> <td>Empatica Srl</td> <td>Neurology</td> <td>POS</td> </tr> <tr> <td>02/13/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231855" target="_parent">K231855</a></td> <td>QOCA image Smart RT Contouring System</td> <td>Quanta Computer Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>02/13/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233788" target="_parent">K233788</a></td> <td>EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System</td> <td>Philips Ultrasound LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>02/09/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231355" target="_parent">K231355</a></td> <td>Aurora</td> <td>EnsoData</td> <td>Anesthesiology</td> <td>MNR</td> </tr> <tr> <td>02/08/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233080" target="_parent">K233080</a></td> <td>HealthFLD</td> <td>Nano-X AI Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>02/05/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232363" target="_parent">K232363</a></td> <td>Viz HDS, Viz Volume Plus, Viz ICH+</td> <td>Viz.ai, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>01/31/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231396" target="_parent">K231396</a></td> <td>CEPHX- Cephalometric Analysis Software</td> <td>Orca Dental AI LTD</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/24/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233195" target="_parent">K233195</a></td> <td>Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>01/19/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233728" target="_parent">K233728</a></td> <td>SIGNA Champion</td> <td>GE Healthcare (Tianjin) Company Limited</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>01/19/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232156" target="_parent">K232156</a></td> <td>Rapid ASPECTS (v3)</td> <td>iSchemaView, Inc.</td> <td>Radiology</td> <td>POK</td> </tr> <tr> <td>01/18/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232698" target="_parent">K232698</a></td> <td>NemoScan</td> <td>Software Nemotec S.L.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>01/17/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231871" target="_parent">K231871</a></td> <td>Radify Triage</td> <td>Envisionit DeepAI Ltd</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>01/16/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233512" target="_parent">K233512</a></td> <td>Rapid (6.0)</td> <td>iSchemaView, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>01/13/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233216" target="_parent">K233216</a></td> <td>CLEWICU System</td> <td>Clew Medical Ltd.</td> <td>Cardiovascular</td> <td>QNL</td> </tr> <tr> <td>01/12/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233677" target="_parent">K233677</a></td> <td>Biograph VK10</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>01/12/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233964" target="_parent">K233964</a></td> <td>GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)</td> <td>Cosmo Artificial Intelligence - AI Ltd</td> <td>Gastroenterology-Urology</td> <td>QNP</td> </tr> <tr> <td>01/11/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232250" target="_parent">K232250</a></td> <td>SurgiCount+ System</td> <td>Stryker Instruments</td> <td>General and Plastic Surgery</td> <td>PBZ</td> </tr> <tr> <td>01/08/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231324" target="_parent">K231324</a></td> <td>DASI Dimensions (V1.0)</td> <td>DASI Simulations</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>01/08/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232412" target="_parent">K232412</a></td> <td>LungQ v3.0.0</td> <td>Thirona BV</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>01/07/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231068" target="_parent">K231068</a></td> <td>autoSCORE</td> <td>Holberg EEG AS</td> <td>Neurology</td> <td>OMB</td> </tr> <tr> <td>01/05/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231917" target="_parent">K231917</a></td> <td>VEA Align</td> <td>EOS imaging</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>01/04/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232808" target="_parent">K232808</a></td> <td>Butterfly iQ3 Ultrasound System</td> <td>Butterfly Network, Inc.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>01/03/2024</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231779" target="_parent">K231779</a></td> <td>REMI AI Discrete Detection Module</td> <td>Epitel, Inc.</td> <td>Neurology</td> <td>OMB</td> </tr> <tr> <td>12/26/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231130" target="_parent">K231130</a></td> <td>TumorSight Viz</td> <td>SimBioSys, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232535" target="_parent">K232535</a></td> <td>MAGNETOM Sola; MAGNETOM Altea</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>12/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232479" target="_parent">K232479</a></td> <td>ART-Plan</td> <td>TheraPanacea</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>12/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231805" target="_parent">K231805</a></td> <td>qXR-LN</td> <td>Qure.ai Technologies</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>12/21/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233112" target="_parent">K233112</a></td> <td>HM70 EVO Diagnostic Ultrasound System</td> <td>Samsung Medison Co., Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>12/20/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230850" target="_parent">K230850</a></td> <td>United Orthopedic Knee Patient Specific Instrumentation</td> <td>Enhatch, Inc.</td> <td>Orthopedic</td> <td>OOG</td> </tr> <tr> <td>12/20/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233176" target="_parent">K233176</a></td> <td>uOmnispace.MI</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/18/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231587" target="_parent">K231587</a></td> <td>MAGNETOM Cima.X</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>12/18/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231929" target="_parent">K231929</a></td> <td>iQ-solutions</td> <td>Sydney Neuroimaging Analysis Centre Pty Ltd</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/15/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230751" target="_parent">K230751</a></td> <td>EW10-EC02 Endoscopy Support Program</td> <td>FUJIFILM Corporation</td> <td>Gastroenterology-Urology</td> <td>QNP</td> </tr> <tr> <td>12/15/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232384" target="_parent">K232384</a></td> <td>Videa Dental Assist</td> <td>VideaHealth, Inc.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>12/14/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231570" target="_parent">K231570</a></td> <td>StrokeViewer Perfusion</td> <td>NICo-Lab B.V.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232231" target="_parent">K232231</a></td> <td>QP-Brain</td> <td>Quibim S.L.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232237" target="_parent">K232237</a></td> <td>Tyto Insights for Wheeze Detection</td> <td>Tyto Care Ltd.</td> <td>Anesthesiology</td> <td>PHZ</td> </tr> <tr> <td>12/11/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232096" target="_parent">K232096</a></td> <td>Transpara Density 1.0.0</td> <td>Screenpoint Medical B.V.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/08/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223757" target="_parent">K223757</a></td> <td>Bonelogic</td> <td>Disior Ltd</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/08/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231898" target="_parent">K231898</a></td> <td>DTX Studio Clinic (4.0)</td> <td>Nobel Biocare AB</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/07/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232661" target="_parent">K232661</a></td> <td>Myocardial Strain Software Application</td> <td>Circle Cardiovascular Imaging</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/07/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232381" target="_parent">K232381</a></td> <td>LOGIQ Totus</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics,</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>12/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233334" target="_parent">K233334</a></td> <td>Aquilion Serve SP (TSX-307B/1) V1.3</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>12/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233562" target="_parent">K233562</a></td> <td>LINQ II Insertable Cardiac Monitor</td> <td>Medtronic, Inc.</td> <td>Cardiovascular</td> <td>MXD</td> </tr> <tr> <td>12/05/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232440" target="_parent">K232440</a></td> <td>Adravision Perio</td> <td>Adra Corporation</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/05/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233568" target="_parent">K233568</a></td> <td>Ceevra Reveal 3+</td> <td>Ceevra, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/01/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232856" target="_parent">K232856</a></td> <td>Syngo Carbon Clinicals</td> <td>Siemens Healthcare GmbH</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/30/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233545" target="_parent">K233545</a></td> <td>EPIQ Series Diagnostic Ultrasound System</td> <td>Philips Ultrasound LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>11/29/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230179" target="_parent">K230179</a></td> <td>6440 MyLabX90</td> <td>Esaote S.p.A.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>11/28/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231631" target="_parent">K231631</a></td> <td>BriefCase-Quantification</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>11/28/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232000" target="_parent">K232000</a></td> <td>syngo.via MI Workflows; Scenium; syngo MBF</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/27/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233243" target="_parent">K233243</a></td> <td>ClearPoint System (Software Version 2.2)</td> <td>ClearPoint Neuro Inc.</td> <td>Neurology</td> <td>HAW</td> </tr> <tr> <td>11/21/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232496" target="_parent">K232496</a></td> <td>Brainomix 360 Triage Stroke</td> <td>Brainomix Limited</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>11/17/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232501" target="_parent">K232501</a></td> <td>AI Platform (AIP001)</td> <td>Exo Inc</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/15/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232841" target="_parent">K232841</a></td> <td>Axial3D Insight</td> <td>Axial Medical Printing Limited</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/14/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232494" target="_parent">K232494</a></td> <td>MAGNETOM Avanto fit; MAGNETOM Skyra fit</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>11/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232083" target="_parent">K232083</a></td> <td>BriefCase-Quantification</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232257" target="_parent">K232257</a></td> <td>Clarius Bladder AI</td> <td>Clarius Mobile Health Corp.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/09/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231617" target="_parent">K231617</a></td> <td>MAGNETOM Free.Max; MAGNETOM Free.Star</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>11/09/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223754" target="_parent">K223754</a></td> <td>BraveCX</td> <td>Bering Ltd</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>11/08/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230534" target="_parent">K230534</a></td> <td>BriefCase-Quantification</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/08/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231765" target="_parent">K231765</a></td> <td>Contour ProtegeAI</td> <td>MIM Software Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>11/07/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231966" target="_parent">K231966</a></td> <td>LOGIQ E10</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics,</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>11/07/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231989" target="_parent">K231989</a></td> <td>LOGIQ E10s, LOGIQ Fortis</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics,</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>11/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231470" target="_parent">K231470</a></td> <td>Lunit INSIGHT DBT</td> <td>Lunit Inc.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>11/03/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231955" target="_parent">K231955</a></td> <td>aprevo Digital Segmentation</td> <td>Carlsmed, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>10/30/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232145" target="_parent">K232145</a></td> <td>ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>10/30/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232751" target="_parent">K232751</a></td> <td>BriefCase-Triage</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>10/30/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231965" target="_parent">K231965</a></td> <td>Voluson Expert 22, Voluson Expert 20, Voluson Expert 18</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics,</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>10/27/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230854" target="_parent">K230854</a></td> <td>SwiftMR</td> <td>AIRS Medical Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/27/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232045" target="_parent">K232045</a></td> <td>MeVis Liver Suite</td> <td>MeVis Medical Solutions AG</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>10/26/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232500" target="_parent">K232500</a></td> <td>Lumify Diagnostic Ultrasound System</td> <td>Philips Ultrasound</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>10/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230842" target="_parent">K230842</a></td> <td>SignalHF (IM008)</td> <td>Implicity Inc.</td> <td>Cardiovascular</td> <td>QNL</td> </tr> <tr> <td>10/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232436" target="_parent">K232436</a></td> <td>Rapid SDH</td> <td>iSchemaView, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>10/23/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232305" target="_parent">K232305</a></td> <td>AI-Rad Companion Brain MR</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>10/23/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231560" target="_parent">K231560</a></td> <td>MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>10/23/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231764" target="_parent">K231764</a></td> <td>Ultrasound System 1300</td> <td>BK Medical Aps</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>10/20/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230209" target="_parent">K230209</a></td> <td>Sonix Health</td> <td>Ontact Health Co., Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>10/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230370" target="_parent">K230370</a></td> <td>SpotLight/SpotLight Duo (with DLIR option)</td> <td>Arineta Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>10/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231642" target="_parent">K231642</a></td> <td>Veuron-Brain-pAb3</td> <td>Heuron Co., Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/11/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230220" target="_parent">K230220</a></td> <td>NeuViz 128 Multi-Slice CT Scanner System</td> <td>Neusoft Medical Systems Co., Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>10/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223905" target="_parent">K223905</a></td> <td>Vivio LVEDP System</td> <td>Avicena, LLC</td> <td>Cardiovascular</td> <td>QUO</td> </tr> <tr> <td>10/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230144" target="_parent">K230144</a></td> <td>Denti.AI Detect</td> <td>Denti.AI Technology, Inc.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>10/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232760" target="_parent">K232760</a></td> <td>Swoop Portable MR Imaging System</td> <td>Hyperfine, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>10/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232787" target="_parent">K232787</a></td> <td>ScanNav Anatomy Peripheral Nerve Block</td> <td>Intelligent Ultrasound Limited</td> <td>Anesthesiology</td> <td>QRG</td> </tr> <tr> <td>10/05/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232704" target="_parent">K232704</a></td> <td>Clarius Ultrasound Scanner</td> <td>Clarius Mobile Health Corp.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>10/05/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231001" target="_parent">K231001</a></td> <td>DeepTek CXR Analyzer v1.0</td> <td>DeepTek Medical Imaging Pvt Ltd</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>10/05/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232367" target="_parent">K232367</a></td> <td>cmAngio V1.0</td> <td>CureMetrix, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>10/04/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231025" target="_parent">K231025</a></td> <td>EFAI NeuroSuite CT ICH Assessment System</td> <td>Ever Fortune.AI Co., Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>10/04/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232023" target="_parent">K232023</a></td> <td>Momentum Spine</td> <td>Momentum Health Inc.</td> <td>Physical Medicine</td> <td>LDK</td> </tr> <tr> <td>10/04/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231398" target="_parent">K231398</a></td> <td>VUNO Med-DeepBrain</td> <td>VUNO Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>10/03/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230085" target="_parent">K230085</a></td> <td>Lung-CAD</td> <td>Imagen Technologies, Inc</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>10/03/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231772" target="_parent">K231772</a></td> <td>V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System</td> <td>Samsung Medison Co., Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>10/03/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232712" target="_parent">K232712</a></td> <td>uMI Panorama</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>09/29/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230045" target="_parent">K230045</a></td> <td>HipCheck</td> <td>Stryker Corp.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>09/28/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231837" target="_parent">K231837</a></td> <td>Brainomix 360 Triage LVO</td> <td>Brainomix Limited</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>09/28/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232699" target="_parent">K232699</a></td> <td>Low Ejection Fraction AI-ECG Algorithm</td> <td>Anumana, Inc.</td> <td>Cardiovascular</td> <td>QYE</td> </tr> <tr> <td>09/27/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232616" target="_parent">K232616</a></td> <td>Volta AF-Xplorer</td> <td>Volta Medical</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>09/26/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230252" target="_parent">K230252</a></td> <td>OFIX MIS App</td> <td>Orthofix US LLC</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231928" target="_parent">K231928</a></td> <td>EFAI RTSUITE CT HCAP-Segmentation System</td> <td>Ever Fortune.AI Co., Ltd.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>09/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223659" target="_parent">K223659</a></td> <td>Jazz</td> <td>AI Medical AG</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231767" target="_parent">K231767</a></td> <td>Annalise Enterprise CTB Triage Trauma</td> <td>Annalise-AI Pty Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>09/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231384" target="_parent">K231384</a></td> <td>Annalise Enterprise CTB Triage Trauma</td> <td>Annalise-AI Pty Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>09/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231149" target="_parent">K231149</a></td> <td>qXR-CTR</td> <td>Qure.ai Technologies</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>09/21/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231678" target="_parent">K231678</a></td> <td>Overjet Periapical Radiolucency Assist</td> <td>Overjet, Inc</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>09/19/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221309" target="_parent">K221309</a></td> <td>AI100 with Shonit</td> <td>SigTuple Technologies Pvt. Ltd.</td> <td>Hematology</td> <td>JOY</td> </tr> <tr> <td>09/19/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231281" target="_parent">K231281</a></td> <td>Aquilion Serve (TSX-307A/1) V1.3</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>09/14/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220034" target="_parent">K220034</a></td> <td>NEUROShield</td> <td>In-Med Prognostics L3C</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223811" target="_parent">K223811</a></td> <td>Lung-CAD</td> <td>Imagen Technologies, Inc</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>09/12/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231748" target="_parent">K231748</a></td> <td>Cartesion Prime (PCD-1000A/3) V10.15</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>09/12/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232526" target="_parent">K232526</a></td> <td>XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAA</td> </tr> <tr> <td>09/09/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223864" target="_parent">K223864</a></td> <td>Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial</td> <td>Brainlab AG</td> <td>Neurology</td> <td>HAW</td> </tr> <tr> <td>09/08/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222921" target="_parent">K222921</a></td> <td>Minuteful-kidney test</td> <td>Healthy.io Ltd.</td> <td>Clinical Chemistry</td> <td>JIR</td> </tr> <tr> <td>09/08/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223621" target="_parent">K223621</a></td> <td>DeepXray</td> <td>Alpha Intelligence Manifolds, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>09/08/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231335" target="_parent">K231335</a></td> <td>Cleerly ISCHEMIA</td> <td>Cleerly, Inc</td> <td>Cardiovascular</td> <td>QXZ</td> </tr> <tr> <td>09/08/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232686" target="_parent">K232686</a></td> <td>CorVista System</td> <td>CorVista Health, Inc.</td> <td>Cardiovascular</td> <td>QXX</td> </tr> <tr> <td>09/07/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231207" target="_parent">K231207</a></td> <td>CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)</td> <td>Biosense Webster, Inc.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>09/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232482" target="_parent">K232482</a></td> <td>MAGNETOM Viato.Mobile</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>09/01/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223622" target="_parent">K223622</a></td> <td>FaceHeart Vitals Software Development Kit (FH vitals SDK)</td> <td>FaceHeart Corp.</td> <td>Cardiovascular</td> <td>QME</td> </tr> <tr> <td>08/30/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230355" target="_parent">K230355</a></td> <td>Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>08/28/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223639" target="_parent">K223639</a></td> <td>VisAble.IO</td> <td>TechsoMed</td> <td>Radiology</td> <td>QTZ</td> </tr> <tr> <td>08/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223180" target="_parent">K223180</a></td> <td>AIRAscore</td> <td>AIRAmed GmbH</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/23/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230812" target="_parent">K230812</a></td> <td>Withings Scan Monitor 2.0</td> <td>Withings</td> <td>Cardiovascular</td> <td>DPS</td> </tr> <tr> <td>08/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230899" target="_parent">K230899</a></td> <td>qXR-PTX-PE</td> <td>Qure.ai Technologies</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>08/18/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223539" target="_parent">K223539</a></td> <td>Dreem 3S</td> <td>Beacon Biosignals, Inc.</td> <td>Neurology</td> <td>OLZ</td> </tr> <tr> <td>08/15/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231094" target="_parent">K231094</a></td> <td>Annalise Enterprise CTB Triage-OH</td> <td>Annalise-AI Pty Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>08/03/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230003" target="_parent">DEN230003</a></td> <td>Viz HCM</td> <td>Viz.ai, Inc.</td> <td>Cardiovascular</td> <td>QXO</td> </tr> <tr> <td>08/03/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223133" target="_parent">K223133</a></td> <td>VisiRad XR</td> <td>Imidex Inc.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>08/02/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223553" target="_parent">K223553</a></td> <td>Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine</td> <td>Brainlab AG</td> <td>Orthopedic</td> <td>OLO</td> </tr> <tr> <td>07/27/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231195" target="_parent">K231195</a></td> <td>Brainomix 360 Triage ICH</td> <td>Brainomix Limited</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>07/27/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230074" target="_parent">K230074</a></td> <td>Rapid Aneurysm Triage and Notification</td> <td>iSchemaView, Inc.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>07/26/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231038" target="_parent">K231038</a></td> <td>Global Hypoperfusion Index (GHI) Algorithm</td> <td>Edwards Lifesciences, LLC</td> <td>Cardiovascular</td> <td>QNL</td> </tr> <tr> <td>07/26/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231572" target="_parent">K231572</a></td> <td>uMI Panorama</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>07/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223473" target="_parent">K223473</a></td> <td>ME-APDS™; MAGENTIQ-COLO™</td> <td>Magentiq Eye LTD</td> <td>Gastroenterology-Urology</td> <td>QNP</td> </tr> <tr> <td>07/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230365" target="_parent">K230365</a></td> <td>Sonio Detect</td> <td>Sonio</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>07/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230913" target="_parent">K230913</a></td> <td>ANDI</td> <td>Imeka Solutions, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/24/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223347" target="_parent">K223347</a></td> <td>UltraSight AI Guidance</td> <td>UltraSight Inc</td> <td>Radiology</td> <td>QJU</td> </tr> <tr> <td>07/21/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230150" target="_parent">K230150</a></td> <td>OptimMRI</td> <td>RebrAIn, SAS</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/21/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231173" target="_parent">K231173</a></td> <td>Irregular Rhythm Notification Feature (IRNF)</td> <td>Apple Inc.</td> <td>Cardiovascular</td> <td>QDB</td> </tr> <tr> <td>07/21/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223288" target="_parent">K223288</a></td> <td>Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI</td> <td>Brainlab AG</td> <td>Neurology</td> <td>HAW</td> </tr> <tr> <td>07/20/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230039" target="_parent">K230039</a></td> <td>uOmnispace</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/19/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231157" target="_parent">K231157</a></td> <td>syngo.CT Lung CAD (Version VD30)</td> <td>Siemens Healthcare GmbH</td> <td>Radiology</td> <td>OEB</td> </tr> <tr> <td>07/14/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223106" target="_parent">K223106</a></td> <td>Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)</td> <td>Brainlab AG</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223424" target="_parent">K223424</a></td> <td>Spine Auto Views</td> <td>GE Medical Systems SCS</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>07/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223426" target="_parent">K223426</a></td> <td>ECHELON Synergy MRI system</td> <td>FUJIFILM Healthcare Corporation</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>07/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231833" target="_parent">K231833</a></td> <td>Biograph Vision.X and Biograph Vision.X Edge</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>07/12/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230823" target="_parent">K230823</a></td> <td>AusculThing ACC</td> <td>AusculThing Oy</td> <td>Cardiovascular</td> <td>DQD</td> </tr> <tr> <td>07/10/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223724" target="_parent">K223724</a></td> <td>MOZI TPS</td> <td>Manteia Technologies Co., Ltd</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>07/07/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231668" target="_parent">K231668</a></td> <td>Spine CAMP™ (1.1)</td> <td>Medical Metrics, Inc</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/03/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222745" target="_parent">K222745</a></td> <td>Axial3D Insight</td> <td>Axial Medical Printing Limited</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/29/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230337" target="_parent">K230337</a></td> <td>EarliPoint</td> <td>EarliTec Diagnostics, Inc.</td> <td>Neurology</td> <td>QPF</td> </tr> <tr> <td>06/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230497" target="_parent">K230497</a></td> <td>Bladder AI (AIBV01)</td> <td>Exo Inc</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/20/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231459" target="_parent">K231459</a></td> <td>HepaFatSmart (V2.0.0)</td> <td>Resonance Health Analysis Services Pty Ltd.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>06/16/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223357" target="_parent">K223357</a></td> <td>EyeArt v2.2.0</td> <td>Eyenuk, Inc</td> <td>Ophthalmic</td> <td>PIB</td> </tr> <tr> <td>06/16/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223646" target="_parent">K223646</a></td> <td>IB Lab LAMA</td> <td>IB Lab Gmbh</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/16/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223556" target="_parent">K223556</a></td> <td>DeepCatch</td> <td>MEDICALIP Co., Ltd</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230112" target="_parent">K230112</a></td> <td>CAC Software</td> <td>Imbio, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>06/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223855" target="_parent">K223855</a></td> <td>FEops HEARTguideTM, FEops HEARTguideTM ALPACA</td> <td>FEops NV</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>05/30/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223523" target="_parent">K223523</a></td> <td>Sonic DL</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>05/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223491" target="_parent">K223491</a></td> <td>Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>QBS</td> </tr> <tr> <td>05/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230273" target="_parent">K230273</a></td> <td>Saranas Early Bird Bleed Monitoring System</td> <td>Saranas, Inc.</td> <td>Cardiovascular</td> <td>QFJ</td> </tr> <tr> <td>05/23/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223504" target="_parent">K223504</a></td> <td>Ceribell Status Epilepticus Monitor</td> <td>Ceribell, Inc.</td> <td>Neurology</td> <td>OMB</td> </tr> <tr> <td>05/23/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230096" target="_parent">K230096</a></td> <td>Genius AI Detection 2.0 with CC-MLO Correlation</td> <td>Hologic, Inc.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>05/19/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231143" target="_parent">K231143</a></td> <td>GI Genius System 100 and GI Genius System 200</td> <td>Cosmo Artificial Intelligence - AI, Ltd.</td> <td>Gastroenterology-Urology</td> <td>QNP</td> </tr> <tr> <td>05/19/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212758" target="_parent">K212758</a></td> <td>Autoplaque</td> <td>Cedars-Sinai Medical Center: AIM</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/17/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222728" target="_parent">K222728</a></td> <td>Radiation Planning Assistant (RPA)</td> <td>University of Texas, MD Anderson Cancer Center</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>05/12/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231190" target="_parent">K231190</a></td> <td>EPIQ Series Diagnostic Ultrasound System</td> <td>Philips Ultrasound LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>05/11/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223623" target="_parent">K223623</a></td> <td>SubtleMR (2.3.x)</td> <td>Subtle Medical, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/10/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220437" target="_parent">K220437</a></td> <td>Neurophet AQUA</td> <td>NEUROPHET, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/04/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230082" target="_parent">K230082</a></td> <td>Auto Segmentation</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>05/04/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223771" target="_parent">K223771</a></td> <td>Lumify Diagnostic Ultrasound System</td> <td>Philips Ultrasound</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>05/02/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230977" target="_parent">K230977</a></td> <td>SIS System</td> <td>Surgical Information Sciences, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>05/02/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230292" target="_parent">K230292</a></td> <td>Samsung ECG Monitor Application with Irregular Heart Rhythm Notification</td> <td>Samsung Electronics Co.,Ltd.</td> <td>Cardiovascular</td> <td>QDA</td> </tr> <tr> <td>04/27/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223734" target="_parent">K223734</a></td> <td>ENT EM</td> <td>Brainlab AG</td> <td>Ear Nose & Throat</td> <td>PGW</td> </tr> <tr> <td>04/27/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223212" target="_parent">K223212</a></td> <td>Precision DL</td> <td>GE Healthcare</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>04/26/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230552" target="_parent">K230552</a></td> <td>MR DWI/FLAIR Measurement V1.0</td> <td>Olea Medical</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/26/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230553" target="_parent">K230553</a></td> <td>LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application</td> <td>Medtronic, Inc.</td> <td>Cardiovascular</td> <td>MXD</td> </tr> <tr> <td>04/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222676" target="_parent">K222676</a></td> <td>Ceevra Reveal 3</td> <td>Ceevra, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>04/25/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230223" target="_parent">K230223</a></td> <td>iCAC Device</td> <td>Bunkerhill, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>04/21/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223501" target="_parent">K223501</a></td> <td>ViewFinder Software Version 1.1</td> <td>Elaitra Ltd</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>04/21/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230084" target="_parent">K230084</a></td> <td>HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System</td> <td>Samsung Medison CO., LTD.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>04/20/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223287" target="_parent">K223287</a></td> <td>Velacur</td> <td>Sonic Incytes</td> <td>Radiology</td> <td>IYO</td> </tr> <tr> <td>04/20/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230807" target="_parent">K230807</a></td> <td>Deep Learning Image Reconstruction</td> <td>GE Healthcare Japan Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>04/19/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223552" target="_parent">K223552</a></td> <td>Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial</td> <td>Brainlab AG</td> <td>Neurology</td> <td>HAW</td> </tr> <tr> <td>04/19/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230023" target="_parent">K230023</a></td> <td>ART-Plan</td> <td>Therapanacea SAS</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>04/17/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230772" target="_parent">K230772</a></td> <td>Quantib Prostate</td> <td>Quantib B.V.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/14/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230685" target="_parent">K230685</a></td> <td>AutoContour Model RADAC V3</td> <td>Radformation, Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>04/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230264" target="_parent">K230264</a></td> <td>Ezra Flash</td> <td>Ezra AI Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213986" target="_parent">K213986</a></td> <td>CerebralGo Plus</td> <td>Yukun (Beijing) Technology Co., Ltd</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>04/11/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223830" target="_parent">K223830</a></td> <td>Ultrasound System 2300</td> <td>BK Medical Aps</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>04/07/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230658" target="_parent">K230658</a></td> <td>SKOUT® system</td> <td>Iterative Scopes Inc.</td> <td>Gastroenterology-Urology</td> <td>QNP</td> </tr> <tr> <td>04/07/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230575" target="_parent">K230575</a></td> <td>Limbus Contour</td> <td>Limbus AI Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223774" target="_parent">K223774</a></td> <td>Contour ProtégéAI</td> <td>MIM Software Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>04/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222360" target="_parent">K222360</a></td> <td>AI-Rad Companion (Cardiovascular)</td> <td>Siemens Medical Solutions U.S.A.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>04/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223458" target="_parent">K223458</a></td> <td>Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems</td> <td>Philips Medical Systems Nederland B.V.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>04/05/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223630" target="_parent">K223630</a></td> <td>Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System</td> <td>Medtronic, Inc.</td> <td>Cardiovascular</td> <td>MXD</td> </tr> <tr> <td>04/03/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223240" target="_parent">K223240</a></td> <td>Annalise Enterprise CTB Triage Trauma</td> <td>Annalise-AI Pty Ltd</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>03/31/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213272" target="_parent">K213272</a></td> <td>Formus Hip</td> <td>Formus Labs, Ltd</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>03/31/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220068" target="_parent">K220068</a></td> <td>Butterfly iQ/iQ+ Ultrasound System</td> <td>Butterfly Network, Inc.</td> <td>Radiology</td> <td>IYO</td> </tr> <tr> <td>03/29/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222312" target="_parent">K222312</a></td> <td>RayStation 12A</td> <td>Raysearch Laboratories AB (Publ)</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>03/28/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222174" target="_parent">K222174</a></td> <td>RadioLens v1.0</td> <td>Synapsica</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>03/28/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222179" target="_parent">K222179</a></td> <td>Annalise Enterprise CXR Triage Trauma</td> <td>Annalise-AI Pty Ltd</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>03/28/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222268" target="_parent">K222268</a></td> <td>Annalise Enterprise CXR Triage Trauma</td> <td>Annalise-AI Pty Ltd</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>03/28/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223343" target="_parent">K223343</a></td> <td>MAGNETOM Amira; MAGNETOM Sempra</td> <td>Siemens Medical Solutions USA Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>03/28/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221921" target="_parent">K221921</a></td> <td>DTX Studio Clinic 3.0</td> <td>Nobel Biocare AB</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>03/27/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222746" target="_parent">K222746</a></td> <td>Overjet Caries Assist</td> <td>Overjet, Inc.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>03/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222036" target="_parent">K222036</a></td> <td>MPXA-2000</td> <td>Medipixel, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>03/21/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223490" target="_parent">K223490</a></td> <td>FlightPlan for Embolization</td> <td>GE Medical Systems SCS</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>03/17/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223073" target="_parent">K223073</a></td> <td>AIio</td> <td>AIio, Inc.</td> <td>Gastroenterology-Urology</td> <td>DRG</td> </tr> <tr> <td>03/17/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223443" target="_parent">K223443</a></td> <td>Viz AAA</td> <td>Viz.ai, Inc.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>03/17/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221772" target="_parent">K221772</a></td> <td>NeuroRPM</td> <td>New Touch Digital Inc.</td> <td>Neurology</td> <td>GYD</td> </tr> <tr> <td>03/10/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223325" target="_parent">K223325</a></td> <td>uMI Panorama</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>03/09/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223514" target="_parent">K223514</a></td> <td>Spectral Bone Marrow</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/09/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221706" target="_parent">K221706</a></td> <td>AccuContour</td> <td>Manteia Technologies Co., Ltd.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>03/07/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223726" target="_parent">K223726</a></td> <td>Aquilion Precision (TSX-304A/4) V10.14 with AiCE</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/03/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222819" target="_parent">K222819</a></td> <td>Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/02/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222884" target="_parent">K222884</a></td> <td>Rapid NCCT Stroke</td> <td>iSchemaView Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>03/02/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222176" target="_parent">K222176</a></td> <td>BoneView</td> <td>Gleamer</td> <td>Radiology</td> <td>QBS</td> </tr> <tr> <td>03/01/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221680" target="_parent">K221680</a></td> <td>Xeleris V Processing and Review System</td> <td>GE Healthcare</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/24/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220063" target="_parent">DEN220063</a></td> <td>Caption Interpretation Automated Ejection Fraction Software</td> <td>Caption Health, Inc</td> <td>Radiology</td> <td>QVD</td> </tr> <tr> <td>02/24/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221592" target="_parent">K221592</a></td> <td>AVIEW Lung Nodule CAD</td> <td>Coreline Soft Co., Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/23/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221564" target="_parent">K221564</a></td> <td>Brainomix 360 e-ASPECTS</td> <td>Brainomix Limited</td> <td>Radiology</td> <td>POK</td> </tr> <tr> <td>02/23/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222579" target="_parent">K222579</a></td> <td>Belun Sleep System BLS-10</td> <td>Belun Technology Company Limited</td> <td>Anesthesiology</td> <td>MNR</td> </tr> <tr> <td>02/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230197" target="_parent">K230197</a></td> <td>BoneMRI v1.6</td> <td>MRIguidance B.V</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>02/22/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230208" target="_parent">K230208</a></td> <td>Swoop® Portable MR Imaging System™</td> <td>Hyperfine, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>02/17/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210022" target="_parent">DEN210022</a></td> <td>PMD-200</td> <td>Medasense Biometrics Ltd.</td> <td>Anesthesiology</td> <td>QVE</td> </tr> <tr> <td>02/16/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222755" target="_parent">K222755</a></td> <td>uMR 680</td> <td>Shanghai United Imaging Intelligence Co., Ltd.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>02/16/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223028" target="_parent">K223028</a></td> <td>uCT ATLAS Astound with uWS-CT-Dual Energy Analysis</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>02/15/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222389" target="_parent">K222389</a></td> <td>ZEUS System</td> <td>iRhythm Technologies, Inc.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>02/15/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223407" target="_parent">K223407</a></td> <td>Versana Essential</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics,</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>02/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223439" target="_parent">K223439</a></td> <td>SIGNA Victor</td> <td>GE Healthcare (Tianjin) Company Limited</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>02/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223387" target="_parent">K223387</a></td> <td>V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System</td> <td>Samsung Medison Co., Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>02/06/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223296" target="_parent">K223296</a></td> <td>Videa Perio Assist</td> <td>VideaHealth, Inc</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>02/02/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222803" target="_parent">K222803</a></td> <td>Oncospace</td> <td>Oncospace, Inc.</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>02/01/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223396" target="_parent">K223396</a></td> <td>Rapid RV/LV</td> <td>iSchemaView Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>02/01/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230020" target="_parent">K230020</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>02/01/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222970" target="_parent">K222970</a></td> <td>LVivo IQS</td> <td>DiA Imaging Analysis Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>01/27/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221868" target="_parent">K221868</a></td> <td>QOCA image Smart CXR Image Processing System</td> <td>Quanta Computer Inc.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>01/23/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222406" target="_parent">K222406</a></td> <td>Clarius AI</td> <td>Clarius Mobile Health Corp.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>01/21/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223516" target="_parent">K223516</a></td> <td>VX1+</td> <td>Volta Medical</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>01/18/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222593" target="_parent">K222593</a></td> <td>TruPlan Computed Tomography (CT) Imaging Software</td> <td>Circle Cardiovascular Imaging Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/13/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223502" target="_parent">K223502</a></td> <td>MR Diffusion Perfusion Mismatch V1.0</td> <td>Olea Medical</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/12/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222458" target="_parent">K222458</a></td> <td>AIBOLIT 3D+</td> <td>AIbolit Technologies, LLC</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/11/2023</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223738" target="_parent">K223738</a></td> <td>Alpha Control Liner System (ACLS)</td> <td>Coapt</td> <td>Neurology</td> <td>GXY</td> </tr> <tr> <td>12/23/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223442" target="_parent">K223442</a></td> <td>MR 5300 and MR 7700 R11 MR Systems</td> <td>Philips Medical Systems Nederlands B.V.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>12/23/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K214036" target="_parent">K214036</a></td> <td>AVIEW</td> <td>Coreline Soft Co., Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/22/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223311" target="_parent">K223311</a></td> <td>Philips CT 3500</td> <td>Philips Healthcare (Suzhou) Co., Ltd</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>12/16/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223268" target="_parent">K223268</a></td> <td>BrainInsight</td> <td>Hyperfine, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/16/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220928" target="_parent">K220928</a></td> <td>Overjet Calculus Assist</td> <td>Overjet, Inc.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>12/16/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222275" target="_parent">K222275</a></td> <td>Saige-Density</td> <td>DeepHealth, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/06/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223247" target="_parent">K223247</a></td> <td>Swoop Portable MR Imaging System</td> <td>Hyperfine, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>12/05/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222692" target="_parent">K222692</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>12/01/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220786" target="_parent">K220786</a></td> <td>STAR Apollo Mapping System</td> <td>Rhythm Al, Ltd</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>11/22/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221624" target="_parent">K221624</a></td> <td>Avenda Health AI Prostate Cancer Planning Software</td> <td>Avenda Health, Inc.</td> <td>Radiology</td> <td>POK</td> </tr> <tr> <td>11/22/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221716" target="_parent">K221716</a></td> <td>CINA</td> <td>AVICENNA.AI</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>11/21/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223032" target="_parent">K223032</a></td> <td>SIS System (Version 5.6.0)</td> <td>Surgical Information Sciences, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/18/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221330" target="_parent">K221330</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>11/16/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221762" target="_parent">K221762</a></td> <td>BoneMRI v1.4</td> <td>MRlguidance B.V.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/14/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222428" target="_parent">K222428</a></td> <td>Syngo Dynamics (Version VA40F)</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/10/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220408" target="_parent">K220408</a></td> <td>AVIEW RT ACS</td> <td>Coreline Soft Co., Ltd.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>11/10/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221183" target="_parent">K221183</a></td> <td>AEYE-DS</td> <td>AEYE Health, Inc.</td> <td>Ophthalmic</td> <td>PIB</td> </tr> <tr> <td>11/08/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221552" target="_parent">K221552</a></td> <td>EFAI ChestSuite XR Pneumothorax Assessment System</td> <td>Ever Fortune.AI Co., Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>10/27/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220332" target="_parent">K220332</a></td> <td>uMR Omega with uWS-MR-MRS</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>10/25/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222070" target="_parent">K222070</a></td> <td>EndoNaut</td> <td>Therenva SAS</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/21/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223042" target="_parent">K223042</a></td> <td>Viz LVO ContaCT</td> <td>Viz.Ai, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>10/20/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222361" target="_parent">K222361</a></td> <td>AI-Rad Companion (Musculoskeletal)</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>10/18/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221632" target="_parent">K221632</a></td> <td>Spine CAMP™</td> <td>Medical Metrics, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>10/14/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221305" target="_parent">K221305</a></td> <td>AI-Rad Companion Organs RT</td> <td>Siemens Medical Solutions USA, Inc</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>10/14/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213857" target="_parent">K213857</a></td> <td>HeartFlow Analysis</td> <td>HeartFlow, Inc.</td> <td>Cardiovascular</td> <td>PJA</td> </tr> <tr> <td>10/07/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220709" target="_parent">K220709</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>10/06/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221449" target="_parent">K221449</a></td> <td>Genius AI Detection 2.0</td> <td>Hologic, Inc.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>10/05/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221892" target="_parent">K221892</a></td> <td>VISIONAIR</td> <td>PacificMD Biotech Llc</td> <td>Ear Nose & Throat</td> <td>BXQ</td> </tr> <tr> <td>09/30/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211611" target="_parent">K211611</a></td> <td>QIR Suite</td> <td>CASIS Cardiac Simulation & Imaging Software</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>09/29/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220080" target="_parent">K220080</a></td> <td>CogNet QmTRIAGE</td> <td>MedCognetics, Inc.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>09/28/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222329" target="_parent">K222329</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>09/27/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221738" target="_parent">K221738</a></td> <td>NS-HGlio</td> <td>Neosoma Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>09/21/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221179" target="_parent">K221179</a></td> <td>SomnoMetry</td> <td>Neumetry Medical Inc</td> <td>Neurology</td> <td>OLZ</td> </tr> <tr> <td>09/20/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213353" target="_parent">K213353</a></td> <td>Aorta-CAD</td> <td>Imagen Technologies, Inc.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>09/13/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221733" target="_parent">K221733</a></td> <td>MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>09/12/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220986" target="_parent">K220986</a></td> <td>Aquilion Precision (TSX-304A/4) V10.10 with AiCE</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>09/12/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221456" target="_parent">K221456</a></td> <td>Rapid ICH</td> <td>iSchemaView Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>09/08/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222076" target="_parent">K222076</a></td> <td>EFAI ChestSuite XR Pleural Effusion Assessment System</td> <td>Ever Fortune.AI Co., Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>09/07/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220783" target="_parent">K220783</a></td> <td>syngo.via RT Image Suite</td> <td>Siemens Medical Solutions USA Inc.</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>09/06/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213960" target="_parent">K213960</a></td> <td>LiverMultiScan v5 (LMSv5)</td> <td>Perspectum</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>09/01/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221241" target="_parent">K221241</a></td> <td>DrAid for Radiology v1</td> <td>VinBrain Joint Stock Company</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>08/29/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221100" target="_parent">K221100</a></td> <td>Viz RV/LV</td> <td>Viz.Ai, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>08/26/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222277" target="_parent">K222277</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>08/25/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221962" target="_parent">K221962</a></td> <td>LINQ II Insertable Cardiac Monitor</td> <td>Medtronic, Inc.</td> <td>Cardiovascular</td> <td>MXD</td> </tr> <tr> <td>08/25/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211841" target="_parent">K211841</a></td> <td>MRI Planner</td> <td>Spectronic Medical AB</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>08/24/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220598" target="_parent">K220598</a></td> <td>AutoContour Model RADAC V2</td> <td>Radformation, Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>08/22/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221599" target="_parent">K221599</a></td> <td>HS40 Diagnostic Ultrasound System</td> <td>Samsung Medison Co., Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>08/19/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222172" target="_parent">K222172</a></td> <td>MI View&GO</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>08/12/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213686" target="_parent">K213686</a></td> <td>SKOUT Software</td> <td>Iterative Scopes Inc</td> <td>Gastroenterology-Urology</td> <td>QNP</td> </tr> <tr> <td>08/12/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220349" target="_parent">K220349</a></td> <td>TeraRecon Neuro</td> <td>TeraRecon, Inc</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/11/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213713" target="_parent">K213713</a></td> <td>AI-Rad Companion (Pulmonary)</td> <td>Siemens Healthcare GmBh</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>08/08/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213645" target="_parent">K213645</a></td> <td>ClearPoint Maestro Brain Model</td> <td>ClearPoint Neuro, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>08/03/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221347" target="_parent">K221347</a></td> <td>Transpara 1.7.2</td> <td>ScreenPoint Medical B.V.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>08/03/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221432" target="_parent">K221432</a></td> <td>Customize</td> <td>3D-Side SA</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/29/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213760" target="_parent">K213760</a></td> <td>ABMD Software</td> <td>HeartLung Corporation</td> <td>Radiology</td> <td>KGI</td> </tr> <tr> <td>07/29/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220961" target="_parent">K220961</a></td> <td>Deep Learning Image Reconstruction</td> <td>GE Healthcare Japan Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>07/28/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213998" target="_parent">K213998</a></td> <td>cvi42 Auto Imaging Software Application</td> <td>Circle Cardiovascular Imaging Inc</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/28/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221923" target="_parent">K221923</a></td> <td>Swoop Portable MR Imaging System</td> <td>Hyperfine, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>07/27/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210822" target="_parent">K210822</a></td> <td>DeepRhythmAI</td> <td>Medicalgorithmics S.A.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>07/25/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220439" target="_parent">K220439</a></td> <td>Viz SDH</td> <td>Viz.ai, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>07/22/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220624" target="_parent">K220624</a></td> <td>AI4CMR v1.0</td> <td>AI4MedImaging Medical Solutions S.A.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>07/22/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220882" target="_parent">K220882</a></td> <td>Vivid E80, Vivid E90, Vivid E95</td> <td>GE Medical Systems Ultrasound and</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>07/22/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220940" target="_parent">K220940</a></td> <td>EchoPAC Software Only, EchoPAC Plug-in</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics,</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/20/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220956" target="_parent">K220956</a></td> <td>Libby Echo:Prio</td> <td>Dyad Medical, Inc</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/19/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213409" target="_parent">K213409</a></td> <td>ZEUS System (Zio Watch)</td> <td>iRhythm Technologies, Inc.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>07/19/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220815" target="_parent">K220815</a></td> <td>BrainInsight</td> <td>Hyperfine, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/19/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213357" target="_parent">K213357</a></td> <td>Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor</td> <td>Verily Life Sciences LLC</td> <td>Cardiovascular</td> <td>DXH</td> </tr> <tr> <td>07/18/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221148" target="_parent">K221148</a></td> <td>Vivid iq</td> <td>GE Medical Systems Ultrasound & Primary Care Diagnostics LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>07/18/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221147" target="_parent">K221147</a></td> <td>Vivid T8, Vivid T9</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics,</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>07/15/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220619" target="_parent">K220619</a></td> <td>Vivid S60N, Vivid S70N</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics,</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>07/14/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221203" target="_parent">K221203</a></td> <td>AHI System</td> <td>Fifth Eye Inc.</td> <td>Cardiovascular</td> <td>QNV</td> </tr> <tr> <td>07/13/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221727" target="_parent">K221727</a></td> <td>syngo.CT Extended Functionality</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>07/08/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212783" target="_parent">K212783</a></td> <td>ProstatID</td> <td>ScanMed, LLC</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>07/06/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210069" target="_parent">K210069</a></td> <td>Minuteful - kidney test</td> <td>Healthy.io Ltd.</td> <td>Clinical Chemistry</td> <td>JIR</td> </tr> <tr> <td>06/29/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213794" target="_parent">K213794</a></td> <td>Eko Murmur Analysis Software (EMAS)</td> <td>Eko Devices, Inc.</td> <td>Cardiovascular</td> <td>DQD</td> </tr> <tr> <td>06/29/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220975" target="_parent">K220975</a></td> <td>V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System</td> <td>Samsung Medison Co., Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>06/27/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220848" target="_parent">K220848</a></td> <td>Venue Fit</td> <td>GE Medical Systems</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>06/27/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220851" target="_parent">K220851</a></td> <td>Venue</td> <td>GE Medical Systems</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>06/24/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220575" target="_parent">K220575</a></td> <td>MAGNETOM Free.Max, MAGNETOM Free.Star</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>06/23/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220497" target="_parent">K220497</a></td> <td>CoLumbo</td> <td>Smart Soft Healthcare AD</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/21/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220800" target="_parent">K220800</a></td> <td>Venue Go</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>06/17/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220813" target="_parent">K220813</a></td> <td>ART-PLAN</td> <td>TheraPanacea</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>06/17/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221463" target="_parent">K221463</a></td> <td>ElucidVivo A.3</td> <td>Elucid Bioimaging Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>06/17/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213037" target="_parent">K213037</a></td> <td>IDx-DR v2.3</td> <td>Digital Diagnostics Inc.</td> <td>Ophthalmic</td> <td>PIB</td> </tr> <tr> <td>06/16/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213504" target="_parent">K213504</a></td> <td>Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>06/10/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221393" target="_parent">K221393</a></td> <td>Swoop Portable MR Imaging System</td> <td>Hyperfine, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>06/08/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213882" target="_parent">K213882</a></td> <td>EarliPoint System</td> <td>EarliTec Diagnostics, Inc.</td> <td>Neurology</td> <td>QPF</td> </tr> <tr> <td>06/08/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213717" target="_parent">K213717</a></td> <td>AIR Recon DL</td> <td>GE Medical Systems,LLC (GE Healthcare)</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>06/06/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220358" target="_parent">K220358</a></td> <td>Voluson Expert 22, Voluson Expert 20, Voluson Expert 18</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics,</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>06/03/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213971" target="_parent">K213971</a></td> <td>Atrial Fibrillation History Feature</td> <td>Apple Inc.</td> <td>Cardiovascular</td> <td>QDB</td> </tr> <tr> <td>06/03/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221314" target="_parent">K221314</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>06/02/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220164" target="_parent">K220164</a></td> <td>Rayvolve</td> <td>AZmed SAS</td> <td>Radiology</td> <td>QBS</td> </tr> <tr> <td>05/31/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220766" target="_parent">K220766</a></td> <td>eMurmur Heart AI</td> <td>CSD Labs GmbH</td> <td>Cardiovascular</td> <td>DQD</td> </tr> <tr> <td>05/31/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221248" target="_parent">K221248</a></td> <td>Rapid LVO</td> <td>iSchemaView, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>05/25/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220416" target="_parent">K220416</a></td> <td>SwiftMR</td> <td>AIRS Medical Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/17/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221219" target="_parent">K221219</a></td> <td>syngo.CT CaScoring</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>05/17/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220499" target="_parent">K220499</a></td> <td>Rapid PE Triage and Notification (PETN)</td> <td>iSchemaView Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>05/17/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221240" target="_parent">K221240</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>05/16/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213583" target="_parent">K213583</a></td> <td>Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems</td> <td>Philips Medical Systems Nederland B.V.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>05/13/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221106" target="_parent">K221106</a></td> <td>Quantib Prostate</td> <td>Quantib BV</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/13/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220589" target="_parent">K220589</a></td> <td>MAGNETOM Skyra Fit</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>05/12/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220105" target="_parent">K220105</a></td> <td>Saige-Dx</td> <td>DeepHealth, Inc.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>05/11/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220446" target="_parent">K220446</a></td> <td>Versana Balance</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics,</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>05/10/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212519" target="_parent">K212519</a></td> <td>Overjet Caries Assist</td> <td>Overjet, Inc.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>05/06/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211966" target="_parent">K211966</a></td> <td>Segment 3DPrint</td> <td>Medviso AB</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/03/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220013" target="_parent">K220013</a></td> <td>X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application</td> <td>Scopio Labs Ltd.</td> <td>Hematology</td> <td>JOY</td> </tr> <tr> <td>05/03/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212915" target="_parent">K212915</a></td> <td>MVision AI Segmentation</td> <td>MVision AI</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>04/29/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220899" target="_parent">K220899</a></td> <td>Oxehealth Vital Signs</td> <td>Oxehealth Limited</td> <td>Cardiovascular</td> <td>QME</td> </tr> <tr> <td>04/29/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220939" target="_parent">K220939</a></td> <td>MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A</td> <td>Siemens Medical Solutions USA Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>04/29/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220590" target="_parent">K220590</a></td> <td>aPROMISE X</td> <td>EXINI Diagnostics AB</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/28/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220264" target="_parent">K220264</a></td> <td>EFAI RTSuite CT HN-Segmentation System</td> <td>Ever Fortune.AI Co., Ltd.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>04/27/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212441" target="_parent">K212441</a></td> <td>Philips Incisive CT</td> <td>Philips Healthcare (Suzhou) Co., Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>04/26/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212662" target="_parent">K212662</a></td> <td>AliveCor QT Service</td> <td>AliveCor, Inc.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>04/26/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213886" target="_parent">K213886</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>04/22/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213944" target="_parent">K213944</a></td> <td>HealthOST</td> <td>NanoxAI Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>04/21/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213795" target="_parent">K213795</a></td> <td>Videa Caries Assist</td> <td>VideaHealth, Inc</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>04/15/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220141" target="_parent">K220141</a></td> <td>RayStation 11B</td> <td>RaySearch Laboratories AB (publ)</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>04/15/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213706" target="_parent">K213706</a></td> <td>AI-Rad Companion Brain MR</td> <td>Siemens Healthcare GmBh</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>04/08/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212274" target="_parent">K212274</a></td> <td>INT Contour</td> <td>Carina Medical LLC</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>04/08/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220192" target="_parent">K220192</a></td> <td>Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>04/06/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203783" target="_parent">K203783</a></td> <td>ClariPulmo</td> <td>ClariPi Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/05/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K214081" target="_parent">K214081</a></td> <td>MRCAT Head & Neck</td> <td>Philips Oy</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>04/05/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220043" target="_parent">K220043</a></td> <td>HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System</td> <td>Samsung Medison Co., Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>04/04/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212624" target="_parent">K212624</a></td> <td>EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System</td> <td>Ever Fortune. AI Co., Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>04/01/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213657" target="_parent">K213657</a></td> <td>DEEPVESSEL FFR</td> <td>KeyaMed NA Inc.</td> <td>Cardiovascular</td> <td>PJA</td> </tr> <tr> <td>04/01/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220151" target="_parent">K220151</a></td> <td>MAGNETOM Avanto Fit</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>03/22/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200828" target="_parent">K200828</a></td> <td>Athelas Home</td> <td>Athelas Inc.</td> <td>Hematology</td> <td>GKZ</td> </tr> <tr> <td>03/22/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212960" target="_parent">K212960</a></td> <td>Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>03/21/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213721" target="_parent">K213721</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>03/16/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213779" target="_parent">K213779</a></td> <td>Customize</td> <td>3D-Side SA</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>03/14/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203744" target="_parent">K203744</a></td> <td>Arterys MICA</td> <td>Arterys Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>03/14/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K214043" target="_parent">K214043</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>03/11/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213725" target="_parent">K213725</a></td> <td>CardIQ Suite</td> <td>GE Medical Systems SCS</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/10/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213566" target="_parent">K213566</a></td> <td>ClearRead Xray Pneumothorax</td> <td>Riverain Technologies, Inc.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>03/04/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210365" target="_parent">K210365</a></td> <td>Second Opinion</td> <td>Pearl Inc.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>03/01/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212365" target="_parent">K212365</a></td> <td>BoneView</td> <td>Gleamer</td> <td>Radiology</td> <td>QBS</td> </tr> <tr> <td>02/25/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213693" target="_parent">K213693</a></td> <td>MAGNETOM Vida with syngo MR XA50A</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>02/24/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213941" target="_parent">K213941</a></td> <td>Annalise Enterprise CXR Triage Pneumothorax</td> <td>Annalise-AI</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>02/18/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213319" target="_parent">K213319</a></td> <td>Viz ANEURYSM, Viz ANX</td> <td>Viz.ai, Inc.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>02/18/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213999" target="_parent">K213999</a></td> <td>Deep Learning Image Reconstruction</td> <td>GE Medical Systems</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>02/11/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213603" target="_parent">K213603</a></td> <td>SIGNA Artist Evo</td> <td>GE Healthcare(Tianjin) Company Limited</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>02/08/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213165" target="_parent">K213165</a></td> <td>Rapid</td> <td>iSchema View Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/04/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212654" target="_parent">K212654</a></td> <td>Micro C Medical Imaging System, M01</td> <td>OXOS Medical, Inc.</td> <td>Radiology</td> <td>IZL</td> </tr> <tr> <td>02/04/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213938" target="_parent">K213938</a></td> <td>Revolution Ascend</td> <td>GE Healthcare Japan Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>02/03/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213976" target="_parent">K213976</a></td> <td>Contour ProtegeAI</td> <td>MIM Software Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>01/28/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203260" target="_parent">K203260</a></td> <td>syngo.CT Brain Hemorrhage</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>01/24/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212333" target="_parent">K212333</a></td> <td>Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>01/20/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K214019" target="_parent">K214019</a></td> <td>syngo.CT Extended Functionality</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>01/20/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213668" target="_parent">K213668</a></td> <td>SIGNA Hero</td> <td>GE Healthcare (GE Medical Systems, LLC)</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>01/19/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210747" target="_parent">K210747</a></td> <td>Caption Interpretation Automated Ejection Fraction Software</td> <td>Caption Health</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>01/19/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212012" target="_parent">K212012</a></td> <td>Follicle Clarity</td> <td>Cycle Clarity</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>01/16/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211980" target="_parent">K211980</a></td> <td>SIGNA Prime</td> <td>GE Healthcare (Tianjin) Company Limited</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>01/14/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213737" target="_parent">K213737</a></td> <td>Quantib ND</td> <td>Quantib B.V.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/14/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213307" target="_parent">K213307</a></td> <td>Eclipse II with Smart Noise Cancellation</td> <td>Carestream Health Inc.</td> <td>Radiology</td> <td>MQB</td> </tr> <tr> <td>01/14/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210760" target="_parent">K210760</a></td> <td>Precise Image</td> <td>Philips Medical Systems Nederland, B.V.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>01/12/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212005" target="_parent">K212005</a></td> <td>UNiD Spine Analyzer</td> <td>MEDICREA International, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/07/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211443" target="_parent">K211443</a></td> <td>AIBOLIT 3D+</td> <td>AIbolit Technologies, LLC</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/06/2022</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213544" target="_parent">K213544</a></td> <td>TOMTEC-ARENA</td> <td>TOMTEC Imaging Systems GmbH</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/29/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213776" target="_parent">K213776</a></td> <td>LiverSmart</td> <td>Resonance Health Analysis Services Pty Ltd</td> <td>Radiology</td> <td>PCS</td> </tr> <tr> <td>12/22/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202404" target="_parent">K202404</a></td> <td>BoneMRI</td> <td>MRIguidance B.V</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/21/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210670" target="_parent">K210670</a></td> <td>BU-CAD</td> <td>TaiHao Medical Inc.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>12/21/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212690" target="_parent">K212690</a></td> <td>qXR-BT</td> <td>Qure.ai Technologies</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/20/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213275" target="_parent">K213275</a></td> <td>EchoGo Core (2.0)</td> <td>Ultromics Limited</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/16/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213628" target="_parent">K213628</a></td> <td>VBrain</td> <td>Vysioneer Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>12/16/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212616" target="_parent">K212616</a></td> <td>Koios DS</td> <td>Koios Medical, Inc.</td> <td>Radiology</td> <td>POK</td> </tr> <tr> <td>12/15/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213155" target="_parent">K213155</a></td> <td>RT-Mind-AI</td> <td>MedMind Technology Co., Ltd.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>12/15/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211803" target="_parent">K211803</a></td> <td>HealthPPT</td> <td>Zebra Medical Vision Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>12/09/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212466" target="_parent">K212466</a></td> <td>LVivo Seamless V2.0</td> <td>DiA Imaging Analysis Ltd</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/06/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213096" target="_parent">K213096</a></td> <td>Al-Rad Companion (Pulmonary)</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>12/03/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212219" target="_parent">K212219</a></td> <td>AHI System</td> <td>Fifth Eye Inc.</td> <td>Cardiovascular</td> <td>QNV</td> </tr> <tr> <td>12/01/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213305" target="_parent">K213305</a></td> <td>Vantage Fortian 1.5T</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>11/26/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211541" target="_parent">K211541</a></td> <td>MammoScreen 2.0</td> <td>Therapixel</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>11/19/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211326" target="_parent">K211326</a></td> <td>EndoScreener</td> <td>Chengdu Wision Medical Device Co., LTD.</td> <td>Gastroenterology-Urology</td> <td>QNP</td> </tr> <tr> <td>11/19/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210831" target="_parent">K210831</a></td> <td>OnQ Neuro</td> <td>CorTechs Labs, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/17/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211678" target="_parent">K211678</a></td> <td>Lunit INSIGHT MMG</td> <td>Lunit Inc.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>11/17/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212456" target="_parent">K212456</a></td> <td>Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System</td> <td>Hyperfine, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>11/17/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212336" target="_parent">K212336</a></td> <td>Soteria.AI</td> <td>Omega Medical Imaging, LLC</td> <td>Radiology</td> <td>OWB</td> </tr> <tr> <td>11/16/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212265" target="_parent">K212265</a></td> <td>TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System</td> <td>Shenzhen Mindray Bio-Medical Electronics Co.,LTD</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>11/15/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213436" target="_parent">K213436</a></td> <td>Clarius Ultrasound Scanner</td> <td>Clarius Mobile Health Corp.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>11/10/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211733" target="_parent">K211733</a></td> <td>Lunit INSIGHT CXR Triage</td> <td>Lunit Inc.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>11/03/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210543" target="_parent">K210543</a></td> <td>IM007</td> <td>Implicity, Inc.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>10/29/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211161" target="_parent">K211161</a></td> <td>Critical Care Suite with Endotracheal Tube Positing AI algorithm</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>10/25/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212218" target="_parent">K212218</a></td> <td>Advanced Algorithms for Treatment Management Applications (AATMA)</td> <td>Elekta Solutions AB</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>10/22/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212516" target="_parent">K212516</a></td> <td>IRNF App</td> <td>Apple Inc.</td> <td>Cardiovascular</td> <td>QDB</td> </tr> <tr> <td>10/22/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210807" target="_parent">K210807</a></td> <td>FlightPlan for Liver</td> <td>GE Medical Systems SCS</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/20/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210632" target="_parent">K210632</a></td> <td>Contour ProtegeAI</td> <td>MIM Software Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>10/14/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210999" target="_parent">K210999</a></td> <td>SwiftMR</td> <td>AIRS Medical Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/14/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212261" target="_parent">K212261</a></td> <td>StrokeSENS LVO</td> <td>Circle Neurovascular Imaging, Inc</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>10/12/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212116" target="_parent">K212116</a></td> <td>VBrain-OAR</td> <td>Vysioneer Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>10/02/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202927" target="_parent">K202927</a></td> <td>EYE-SYNC</td> <td>SyncThink, Inc.</td> <td>Neurology</td> <td>QEA</td> </tr> <tr> <td>09/28/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211964" target="_parent">K211964</a></td> <td>SubtlePET</td> <td>Subtle Medical, Inc.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>09/24/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212704" target="_parent">K212704</a></td> <td>Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System</td> <td>Philips Medical Systems</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>09/21/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200080" target="_parent">DEN200080</a></td> <td>Paige Prostate</td> <td>Paige.AI</td> <td>Pathology</td> <td>QPN</td> </tr> <tr> <td>09/17/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212067" target="_parent">K212067</a></td> <td>Deep Learning Image Reconstruction</td> <td>GE Healthcare Japan Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>09/17/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212269" target="_parent">K212269</a></td> <td>Intelligent NR</td> <td>Canon Inc.</td> <td>Radiology</td> <td>MQB</td> </tr> <tr> <td>09/15/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210085" target="_parent">K210085</a></td> <td>HealthCCSng</td> <td>Zebra Medical Vision Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>09/10/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210438" target="_parent">K210438</a></td> <td>Versana Premier</td> <td>GE Medical Systems Ultrasound And Primary Care Diagnostics</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>09/10/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203785" target="_parent">K203785</a></td> <td>ClariSIGMAM</td> <td>ClariPI Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>09/10/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211828" target="_parent">K211828</a></td> <td>Aquilion Exceed LB</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>09/09/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211824" target="_parent">K211824</a></td> <td>HERA W9, HERA W10 Diagnostic Ultrasound System</td> <td>Samsung Medison Co., Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>09/08/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203555" target="_parent">K203555</a></td> <td>AmCAD-UT</td> <td>AmCad BioMed Corporation</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>09/08/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211597" target="_parent">K211597</a></td> <td>EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System</td> <td>Philips Medical Systems</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>09/08/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211945" target="_parent">K211945</a></td> <td>V8 Diagnostic Ultrasound System</td> <td>Samsung Medison CO., LTD.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>09/08/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200030" target="_parent">DEN200030</a></td> <td>Feops HEARTguide</td> <td>Feops NV</td> <td>Cardiovascular</td> <td>QQI</td> </tr> <tr> <td>09/08/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211867" target="_parent">K211867</a></td> <td>RayStation 11.0</td> <td>RaySearch Laboratories AB (publ)</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>09/02/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211881" target="_parent">K211881</a></td> <td>AI Segmentation Varian</td> <td>Medical Systems, Inc.</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>08/31/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212383" target="_parent">K212383</a></td> <td>EndoNaut</td> <td>Therenva SAS</td> <td>Radiology</td> <td>OWB</td> </tr> <tr> <td>08/31/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201560" target="_parent">K201560</a></td> <td>Auto Lung Nodule Detection</td> <td>Samsung Electronics Co.,Ltd.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>08/27/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203696" target="_parent">K203696</a></td> <td>RBknee</td> <td>Radiobotics ApS</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/20/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211846" target="_parent">K211846</a></td> <td>Discovery MI Gen2</td> <td>GE Medical Systems, LLC.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>08/16/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212230" target="_parent">K212230</a></td> <td>TruSPECT Radiological Image Processing Station</td> <td>Spectrum Dynamics Medical Ltd</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/12/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211179" target="_parent">K211179</a></td> <td>InferRead CT Stroke.AI</td> <td>Infervision Medical Technology Co., Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>08/11/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203448" target="_parent">K203448</a></td> <td>uCT ATLAS with uWS-CT-Dual Energy Analysis</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>08/06/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211764" target="_parent">K211764</a></td> <td>Vereos PET/CT</td> <td>Philips Medical Systems Nederland B.V.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>08/06/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212100" target="_parent">K212100</a></td> <td>Kosmos</td> <td>EchoNous, Inc.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>08/02/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211431" target="_parent">K211431</a></td> <td>breastscape v1.0</td> <td>Olea Medical</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/30/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211222" target="_parent">K211222</a></td> <td>qER-Quant</td> <td>Qure.ai Technologies</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/30/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211379" target="_parent">K211379</a></td> <td>syngo.via RT Image Suite</td> <td>Siemens Medical Solutions USA Inc.</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>07/27/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211279" target="_parent">K211279</a></td> <td>Volpara Imaging Software</td> <td>Volpara Health Technologies Limited</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>07/27/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210791" target="_parent">K210791</a></td> <td>Us2.v1</td> <td>eko.ai Pte. Ltd. d/b/a Us2.ai</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/27/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211655" target="_parent">K211655</a></td> <td>aPROMISE</td> <td>EXINI Diagnostics AB</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>07/27/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212074" target="_parent">K212074</a></td> <td>ClariCT.AI</td> <td>ClariPi Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>07/23/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211951" target="_parent">K211951</a></td> <td>GI Genius</td> <td>Cosmo Artificial Intelligence - AI Ltd</td> <td>Gastroenterology-Urology</td> <td>QNP</td> </tr> <tr> <td>07/20/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210719" target="_parent">K210719</a></td> <td>Change Healthcare Anatomical AI</td> <td>Change Healthcare Canada Company</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/20/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211906" target="_parent">K211906</a></td> <td>Vital Signs</td> <td>Oxehealth Limited</td> <td>Cardiovascular</td> <td>QME</td> </tr> <tr> <td>07/20/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210666" target="_parent">K210666</a></td> <td>Chest-CAD</td> <td>Imagen Technologies, Inc</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>07/12/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211506" target="_parent">K211506</a></td> <td>PowerLook Density Assessment Software V4.0</td> <td>ICAD Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/08/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211788" target="_parent">K211788</a></td> <td>HALO</td> <td>Nico.Lab B.V.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>07/01/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210611" target="_parent">K210611</a></td> <td>MAGNETOM Free.Max</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>06/29/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210645" target="_parent">K210645</a></td> <td>RayStation 10.1</td> <td>RaySearch Laboratories AB (publ)</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>06/17/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203514" target="_parent">K203514</a></td> <td>Precise Position</td> <td>Philips Healthcare (Suzhou) Co., Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>06/16/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210034" target="_parent">K210034</a></td> <td>EnsoSleep</td> <td>EnsoData, Inc.</td> <td>Neurology</td> <td>OLZ</td> </tr> <tr> <td>06/16/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202718" target="_parent">K202718</a></td> <td>Qmenta Care Platform Family</td> <td>Mint Labs, Inc., D/B/A. QMENTA</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>06/11/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210484" target="_parent">K210484</a></td> <td>LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System</td> <td>Medtronic, Inc.</td> <td>Cardiovascular</td> <td>MXD</td> </tr> <tr> <td>06/10/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203629" target="_parent">K203629</a></td> <td>IDx-DR</td> <td>Digital Diagnostics Inc.</td> <td>Ophthalmic</td> <td>PIB</td> </tr> <tr> <td>06/10/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211459" target="_parent">K211459</a></td> <td>syngo.via MI WorkFlows, Scenium, syngo MBF</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/08/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210458" target="_parent">K210458</a></td> <td>OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System</td> <td>Abbott Medical</td> <td>Cardiovascular</td> <td>NQQ</td> </tr> <tr> <td>06/02/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210404" target="_parent">K210404</a></td> <td>Transpara 1.7.0</td> <td>ScreenPoint Medical B.V.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>06/02/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200069" target="_parent">DEN200069</a></td> <td>Cognoa Asd Diagnosis Aid</td> <td>Cognoa, Inc.</td> <td>Neurology</td> <td>QPF</td> </tr> <tr> <td>05/21/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202527" target="_parent">K202527</a></td> <td>Zio ECG Utilization Software (ZEUS) System</td> <td>iRhythm Technologies, Inc.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>05/19/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210237" target="_parent">K210237</a></td> <td>CINA CHEST</td> <td>Avicenna.AI</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>05/19/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210187" target="_parent">K210187</a></td> <td>Overjet Dental Assist</td> <td>Overjet, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/14/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201034" target="_parent">K201034</a></td> <td>Syngo.CT CaScoring</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>05/13/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211118" target="_parent">K211118</a></td> <td>SIGNA 7.0T</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>05/13/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210426" target="_parent">K210426</a></td> <td>HS40 Diagnostic Ultrasound System</td> <td>Samsung Medison Co., Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>04/30/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210001" target="_parent">K210001</a></td> <td>HYPER AiR</td> <td>Shanghai United Imaging Healthcare Co.,Ltd.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>04/23/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203502" target="_parent">K203502</a></td> <td>MEDO-Thyroid</td> <td>MEDO DX Pte. Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>04/23/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203314" target="_parent">K203314</a></td> <td>Cartesion Prime (PCD-1000A/3) V10.8</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>04/21/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210556" target="_parent">K210556</a></td> <td>Preview Shoulder</td> <td>Genesis Software Innovations</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>04/20/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203610" target="_parent">K203610</a></td> <td>Automatic Anatomy Recognition (AAR)</td> <td>Quantitative Radiology Solutions, LLC</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>04/19/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203469" target="_parent">K203469</a></td> <td>AI Segmentation</td> <td>Varian Medical Systems</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>04/16/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203517" target="_parent">K203517</a></td> <td>Saige-Q</td> <td>DeepHealth, Inc.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>04/14/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202992" target="_parent">K202992</a></td> <td>BriefCase, RIB Fractures Triage (RibFx)</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>04/09/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200055" target="_parent">DEN200055</a></td> <td>GI Genius</td> <td>Cosmo Artificial Intelligence - AI, Ltd.</td> <td>Gastroenterology-Urology</td> <td>QNP</td> </tr> <tr> <td>04/02/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202441" target="_parent">K202441</a></td> <td>Eclipse II with Smart Noise Cancellation</td> <td>Carestream Health, Inc.</td> <td>Radiology</td> <td>MQB</td> </tr> <tr> <td>04/02/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202928" target="_parent">K202928</a></td> <td>DV.Target</td> <td>DeepVoxel, Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>04/01/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200038" target="_parent">DEN200038</a></td> <td>Gili Pro Biosensor (Also Known as Gili Biosensor System)</td> <td>Continuse Biometrics Ltd.</td> <td>Cardiovascular</td> <td>QOK</td> </tr> <tr> <td>03/31/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203258" target="_parent">K203258</a></td> <td>syngo.CT Lung CAD (Version VD20)</td> <td>Siemens Healthcare GmbH</td> <td>Radiology</td> <td>OEB</td> </tr> <tr> <td>03/31/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203443" target="_parent">K203443</a></td> <td>MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with syngo MR XA31A</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>03/31/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210071" target="_parent">K210071</a></td> <td>SIS System (Version 5.1.0)</td> <td>Surgical Information Sciences, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>03/26/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200019" target="_parent">DEN200019</a></td> <td>Oxehealth Vital Signs</td> <td>Oxehealth Limited</td> <td>Cardiovascular</td> <td>QME</td> </tr> <tr> <td>03/24/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203225" target="_parent">K203225</a></td> <td>AquilionONE(TSX‐306A/3)V10.4withSpectralImagingSystem</td> <td>CanonMedicalSystemsCorporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/23/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210209" target="_parent">K210209</a></td> <td>Viz ICH</td> <td>Viz.Ai, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>03/19/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203235" target="_parent">K203235</a></td> <td>VBrain</td> <td>Vysioneer Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>03/12/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203822" target="_parent">K203822</a></td> <td>ProFound AI Software V3.0</td> <td>ICAD Inc.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>03/12/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202284" target="_parent">K202284</a></td> <td>Oncospace</td> <td>Oncospace, Inc.</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>03/09/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203256" target="_parent">K203256</a></td> <td>Imbio RV/LV Software</td> <td>Imbio, LLC</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>03/05/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202300" target="_parent">K202300</a></td> <td>Optellum Virtual Nodule Clinic, Optellum Software, Optellum Platform</td> <td>Optellum Ltd</td> <td>Radiology</td> <td>POK</td> </tr> <tr> <td>03/04/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203323" target="_parent">K203323</a></td> <td>Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>03/02/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203617" target="_parent">K203617</a></td> <td>MaxFOV 2</td> <td>GE Medical Systems, LLC.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/01/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200022" target="_parent">DEN200022</a></td> <td>Analytic for Hemodynamic Instability (AHI)</td> <td>Fifth Eye Inc.</td> <td>Cardiovascular</td> <td>QNV</td> </tr> <tr> <td>02/26/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203182" target="_parent">K203182</a></td> <td>SubtleMR</td> <td>Subtle Medical, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/25/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202990" target="_parent">K202990</a></td> <td>NinesMeasure</td> <td>Nines, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/25/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203578" target="_parent">K203578</a></td> <td>OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System</td> <td>Perimeter Medical Imaging AI, Inc.</td> <td>General and Plastic Surgery</td> <td>NQQ</td> </tr> <tr> <td>02/19/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202212" target="_parent">K202212</a></td> <td>Truplan</td> <td>Circle Cardiovascular Imaging Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/09/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203103" target="_parent">K203103</a></td> <td>Synapse 3D, Synapse 3D Base Tools v6.1</td> <td>Fujifilm Corporation</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/05/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210053" target="_parent">K210053</a></td> <td>LVivo Software Application</td> <td>DiA Imaging Analysis Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>02/04/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203582" target="_parent">K203582</a></td> <td>QUIBIM Precision Prostate (qp-Prostate)</td> <td>QUIBIM S.L.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/29/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201411" target="_parent">K201411</a></td> <td>Visage Breast Density</td> <td>Visage Imaging GmbH</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>01/15/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193271" target="_parent">K193271</a></td> <td>UAI Easytriage-Rib</td> <td>Shanghai United Imaging Intelligence Co., Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>01/15/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202767" target="_parent">K202767</a></td> <td>Vantage Orian 1.5T, MRT-1550, V6.0</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>01/14/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202700" target="_parent">K202700</a></td> <td>ART-Plan</td> <td>TheraPanacea</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>01/12/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203280" target="_parent">K203280</a></td> <td>Hepatica V1 (Hepatica V1.0.0)</td> <td>Perspectum Ltd.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>01/12/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201836" target="_parent">K201836</a></td> <td>Aquilion Lightning (TSX-036A/7) V10.2 With AiCE-I</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>01/11/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200003" target="_parent">P200003</a></td> <td>Imagio Breast Imaging System</td> <td>Seno Medical Instruments, Inc.</td> <td>Radiology</td> <td>QNK</td> </tr> <tr> <td>01/09/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200717" target="_parent">K200717</a></td> <td>CLEWICU System (ClewICUserver and ClewICUnitor)</td> <td>Clew Medical Ltd.</td> <td>Cardiovascular</td> <td>QNL</td> </tr> <tr> <td>01/08/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203329" target="_parent">K203329</a></td> <td>HeartFlow Analysis</td> <td>HeartFlow, Inc.</td> <td>Cardiovascular</td> <td>PJA</td> </tr> <tr> <td>01/07/2021</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202414" target="_parent">K202414</a></td> <td>BrainInsight</td> <td>Hyperfine Research, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/29/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203508" target="_parent">K203508</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>12/22/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202229" target="_parent">K202229</a></td> <td>AI Metrics</td> <td>AI Metrics, LLC</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/18/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201555" target="_parent">K201555</a></td> <td>EchoGo Pro</td> <td>Ultromics Ltd.</td> <td>Radiology</td> <td>POK</td> </tr> <tr> <td>12/10/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203042" target="_parent">K203042</a></td> <td>Aquilion Exceed LB (TSX-202A/3) V10.6 With AiCE-I</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>12/10/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201745" target="_parent">K201745</a></td> <td>Deep Learning Image Reconstruction For Gemstone Spectral Imaging</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>12/07/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201039" target="_parent">K201039</a></td> <td>HepaFat-AI</td> <td>Resonance Health Analysis Services Pty Ltd.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>12/04/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202487" target="_parent">K202487</a></td> <td>HealthJOINT</td> <td>Zebra Medical Vision Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/20/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200873" target="_parent">K200873</a></td> <td>HALO</td> <td>NICo-Lab B.V.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>11/20/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203169" target="_parent">K203169</a></td> <td>Revolution Ascend</td> <td>GE Healthcare Japan Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>11/20/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193287" target="_parent">K193287</a></td> <td>CorInsights MRI</td> <td>ADM Diagnostics</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/18/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201019" target="_parent">K201019</a></td> <td>Genius AI Detection</td> <td>Hologic, Inc.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>11/18/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201195" target="_parent">K201195</a></td> <td>syngo.via MI Workflows, syngo MBF</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/17/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193306" target="_parent">K193306</a></td> <td>PROView</td> <td>GE Medical Systems SCS</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/12/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193289" target="_parent">K193289</a></td> <td>FastStroke, CT Perfusion 4D</td> <td>GE Medical Systems SCS</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>11/12/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201985" target="_parent">K201985</a></td> <td>KardiaAI</td> <td>AliveCor, Inc.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>11/06/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200750" target="_parent">K200750</a></td> <td>Neuro.Al Algorithm</td> <td>TeraRecon, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/06/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193562" target="_parent">K193562</a></td> <td>AI-Rad Companion Organs RT</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>10/30/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200323" target="_parent">K200323</a></td> <td>Autocontour</td> <td>Radformation, Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>10/30/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202013" target="_parent">K202013</a></td> <td>WRDensity by Whiterabbit.ai</td> <td>Whiterabbit.ai Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>10/28/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202089" target="_parent">K202089</a></td> <td>Lenshooke X1 Pro Semen Quality Analyzer, Lenshooke X1 Pro Se Semen Quality Analyzer</td> <td>Bonraybio Co., Ltd.</td> <td>Hematology</td> <td>POV</td> </tr> <tr> <td>10/16/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200595" target="_parent">K200595</a></td> <td>CellaVision DC-1, CellaVision DC-1 PPA</td> <td>CellaVision AB</td> <td>Hematology</td> <td>JOY</td> </tr> <tr> <td>10/16/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201710" target="_parent">K201710</a></td> <td>A View LCS</td> <td>Coreline Soft Co., Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/15/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201615" target="_parent">K201615</a></td> <td>SIGNA 7.0T</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>10/11/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202501" target="_parent">K202501</a></td> <td>Quantib Prostate</td> <td>Quantib BV</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/09/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193631" target="_parent">K193631</a></td> <td>Stethee Pro 1, Stethee Pro Software System</td> <td>M3DICINE Pty Ltd.</td> <td>Cardiovascular</td> <td>DQD</td> </tr> <tr> <td>10/02/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202280" target="_parent">K202280</a></td> <td>Cleerly Labs V2.0</td> <td>Cleerly, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/02/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202170" target="_parent">K202170</a></td> <td>LiverMultiScan</td> <td>Perspectum Ltd.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>10/02/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201301" target="_parent">K201301</a></td> <td>X100 With Full Field Peripheral Blood Smear (Pbs) Application</td> <td>Scopio Labs Ltd.</td> <td>Hematology</td> <td>JOY</td> </tr> <tr> <td>09/30/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192051" target="_parent">K192051</a></td> <td>THINQ</td> <td>CorticoMetrics LLC</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/29/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202546" target="_parent">K202546</a></td> <td>LVivo Seamless</td> <td>DiA Imaging Analysis Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>09/25/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201103" target="_parent">K201103</a></td> <td>Xeleris V Processing And Review Systems</td> <td>GE Healthcare</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/24/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200569" target="_parent">K200569</a></td> <td>Raystation</td> <td>Raysearch Laboratories Ab (Publ)</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>09/18/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200852" target="_parent">K200852</a></td> <td>EchoPAC Software Only, EchoPAC Plug-In</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/18/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201992" target="_parent">K201992</a></td> <td>Caption Guidance</td> <td>Caption Health</td> <td>Radiology</td> <td>QJU</td> </tr> <tr> <td>09/16/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201298" target="_parent">K201298</a></td> <td>VX1</td> <td>Volta Medical</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>09/16/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201369" target="_parent">K201369</a></td> <td>AVA (Augmented Vascular Analysis)</td> <td>See-Mode Technologies Pte. Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/15/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192665" target="_parent">K192665</a></td> <td>Accelerate Pheno System, Accelerate Phenotest Bc Kit</td> <td>Accelerate Diagnostics, Inc.</td> <td>Microbiology</td> <td>PRH</td> </tr> <tr> <td>09/09/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200708" target="_parent">K200708</a></td> <td>Vivid iq</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>09/09/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200851" target="_parent">K200851</a></td> <td>Vivid T8, Vivid T9</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>09/06/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201841" target="_parent">K201841</a></td> <td>EyeBOX</td> <td>Oculogica, Inc.</td> <td>Neurology</td> <td>QEA</td> </tr> <tr> <td>09/04/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202238" target="_parent">K202238</a></td> <td>SIGNA Artist</td> <td>GE Healthcare (Tianjin) Company Limited</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>09/02/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200833" target="_parent">K200833</a></td> <td>RX-1 Rhythm Express Remote Cardiac Monitoring System</td> <td>VivaQuant Inc.</td> <td>Cardiovascular</td> <td>MLO</td> </tr> <tr> <td>08/26/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200714" target="_parent">K200714</a></td> <td>AVIEW</td> <td>Coreline Soft Co., Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/26/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201020" target="_parent">K201020</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>08/14/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201632" target="_parent">K201632</a></td> <td>Tomtec-Arena</td> <td>Tomtec Imaging Systems Gmbh</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/13/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201444" target="_parent">K201444</a></td> <td>syngo.via RT Image Suite</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>08/13/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201232" target="_parent">K201232</a></td> <td>Limbus Contour</td> <td>Limbus Ai Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/07/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200990" target="_parent">K200990</a></td> <td>Vida|Vision</td> <td>Vida Diagnostics Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>08/07/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201310" target="_parent">K201310</a></td> <td>Accipiolx</td> <td>MaxQ Al Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>08/04/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193210" target="_parent">K193210</a></td> <td>HYPER DLR</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>08/03/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200667" target="_parent">K200667</a></td> <td>EyeArt</td> <td>Eyenuk, Inc</td> <td>Ophthalmic</td> <td>PIB</td> </tr> <tr> <td>07/30/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193283" target="_parent">K193283</a></td> <td>AI-Rad Companion Prostate MR</td> <td>Siemens Medical Solutions USA Inc</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/30/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193417" target="_parent">K193417</a></td> <td>FractureDetect (FX)</td> <td>Imagen Technologies, Inc.</td> <td>Radiology</td> <td>QBS</td> </tr> <tr> <td>07/23/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200743" target="_parent">K200743</a></td> <td>Vivid E80/ Vivid E90/ Vivid E95</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>07/22/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200621" target="_parent">K200621</a></td> <td>Caption Interpretation Automated Ejection Fraction Software</td> <td>Caption Health</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/16/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200497" target="_parent">K200497</a></td> <td>Vivid S60N, Vivid S70N</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>07/16/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200905" target="_parent">K200905</a></td> <td>HealthMammo</td> <td>Zebra Medical Vision Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>07/14/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193097" target="_parent">K193097</a></td> <td>Vantage Orian 1.5T, MRT-1550, V6.0 With AiCE Reconstruction Processing Unit For MR</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>07/10/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192969" target="_parent">K192969</a></td> <td>Ezra Plexo Software</td> <td>Ezra AI Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>07/10/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193294" target="_parent">K193294</a></td> <td>AI-Rad Companion Engine</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>07/09/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200941" target="_parent">K200941</a></td> <td>Rapid LVO</td> <td>iSchemaView, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>07/06/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193073" target="_parent">K193073</a></td> <td>Deep Recon</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>07/02/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192880" target="_parent">K192880</a></td> <td>InferRead Lung CT.AI</td> <td>Beijing Infervision Technology Co.,Ltd.</td> <td>Radiology</td> <td>OEB</td> </tr> <tr> <td>07/02/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193252" target="_parent">K193252</a></td> <td>Contour ProtégéAI</td> <td>MIM Software, Inc.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>06/26/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200760" target="_parent">K200760</a></td> <td>Rapid ASPECTS</td> <td>ISchemaView Inc.</td> <td>Radiology</td> <td>POK</td> </tr> <tr> <td>06/24/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200855" target="_parent">K200855</a></td> <td>CINA</td> <td>AVICENNA.AI</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>06/23/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200232" target="_parent">K200232</a></td> <td>LVivo Software Application</td> <td>DiA Imaging Analysis Ltd</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/19/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193298" target="_parent">K193298</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>06/17/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193290" target="_parent">K193290</a></td> <td>AI-Rad Companion Brain MR</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>06/17/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200921" target="_parent">K200921</a></td> <td>QER</td> <td>Qure.Ai Technologies</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>06/11/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200356" target="_parent">K200356</a></td> <td>MEDO ARIA</td> <td>MEDO.ai</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/11/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200980" target="_parent">K200980</a></td> <td>Auto 3D Bladder Volume Tool</td> <td>Butterfly Network, Inc.</td> <td>Radiology</td> <td>IYO</td> </tr> <tr> <td>06/03/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200974" target="_parent">K200974</a></td> <td>QLAB Advanced Quantification Software</td> <td>Philips Healthcare</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>06/01/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192601" target="_parent">K192601</a></td> <td>uWS-MR</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>05/12/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192901" target="_parent">K192901</a></td> <td>HealthVCF</td> <td>Zebra Medical Vision Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>05/05/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193176" target="_parent">K193176</a></td> <td>uMR 780</td> <td>Shanghai United Imaging Healthcare Co., Ltd.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>05/05/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193220" target="_parent">K193220</a></td> <td>AVIEW LCS</td> <td>Coreline Soft Co., Ltd</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/01/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K201012" target="_parent">K201012</a></td> <td>EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System</td> <td>Philips Ultrasound, Inc.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>04/21/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193351" target="_parent">K193351</a></td> <td>NinesAI</td> <td>Nines, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>04/16/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200755" target="_parent">K200755</a></td> <td>Caption Guidance</td> <td>Caption Health, Inc.</td> <td>Radiology</td> <td>QJU</td> </tr> <tr> <td>04/13/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192167" target="_parent">K192167</a></td> <td>CuraRad-ICH</td> <td>CuraCloud Corp.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>04/10/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193282" target="_parent">K193282</a></td> <td>Signa Premier</td> <td>GE Healthcare (GE Medical Systems, LLC)</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>04/08/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193300" target="_parent">K193300</a></td> <td>AIMI-Triage CXR PTX</td> <td>RADLogics, Inc.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>03/31/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193087" target="_parent">K193087</a></td> <td>Rapid ICH</td> <td>ISchemaView Incorporated</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>03/26/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192732" target="_parent">K192732</a></td> <td>Bodyguardian Remote Monitoring System</td> <td>Preventice Technologies, Inc.</td> <td>Cardiovascular</td> <td>DSI</td> </tr> <tr> <td>03/26/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193518" target="_parent">K193518</a></td> <td>KOSMOS</td> <td>EchoNous, Inc.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>03/25/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192437" target="_parent">K192437</a></td> <td>Arterys MICA</td> <td>Arterys Inc.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>03/25/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192854" target="_parent">K192854</a></td> <td>MammoScreen</td> <td>Therapixel</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>03/20/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193281" target="_parent">K193281</a></td> <td>Hepatic VCAR</td> <td>GE Medical Systems SCS</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/20/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200036" target="_parent">K200036</a></td> <td>AI-ECG Tracker</td> <td>Shenzhen Carewell Electronics Co., Ltd.</td> <td>Cardiovascular</td> <td>DPS</td> </tr> <tr> <td>03/18/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193658" target="_parent">K193658</a></td> <td>Viz ICH</td> <td>Viz.Ai, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>03/16/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193267" target="_parent">K193267</a></td> <td>Al-Rad Companion (Musculoskeletal)</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/12/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192388" target="_parent">K192388</a></td> <td>SonoVision Ultrasound Imaging System</td> <td>Tissue Differentiation Intelligence, LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>03/09/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193216" target="_parent">K193216</a></td> <td>Syngo.CT Lung CAD</td> <td>Siemens Medical Solutions, Inc</td> <td>Radiology</td> <td>OEB</td> </tr> <tr> <td>03/09/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192574" target="_parent">K192574</a></td> <td>Vantage Galan 3T, MRT-3020, V6.0 With AiCE Reconstruction Processing Unit For MR</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>03/05/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193229" target="_parent">K193229</a></td> <td>Transpara</td> <td>Screenpoint Medical B.V.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>03/04/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191550" target="_parent">K191550</a></td> <td>Broncholab</td> <td>Fluidda Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>02/28/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191556" target="_parent">K191556</a></td> <td>Red Dot</td> <td>Behold.AI Technologies Limited</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>02/28/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191928" target="_parent">K191928</a></td> <td>AccuContour</td> <td>Xiamen Manteia Technology Ltd.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>02/28/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192962" target="_parent">K192962</a></td> <td>icobrain-ctp</td> <td>icometrix NV</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/21/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192832" target="_parent">K192832</a></td> <td>Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-I</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>02/19/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192973" target="_parent">K192973</a></td> <td>Densitas Densityai</td> <td>Densitas, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/14/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193248" target="_parent">K193248</a></td> <td>Biograph Vision, Biograph MCT Family Of PET/CTs</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>02/13/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192828" target="_parent">K192828</a></td> <td>Aquilion ONE (TSX-306A/3) V10.0 With Spectral Imaging System</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>02/12/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193178" target="_parent">K193178</a></td> <td>Biograph Horizon PET/CT</td> <td>Siemens Medical Solution USA, Inc.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>02/10/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192377" target="_parent">K192377</a></td> <td>Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon</td> <td>Varian Medical Systems, Inc.</td> <td>Radiology</td> <td>IYE</td> </tr> <tr> <td>02/07/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN190040" target="_parent">DEN190040</a></td> <td>Caption Guidance</td> <td>Bay Labs, Inc.</td> <td>Radiology</td> <td>QJU</td> </tr> <tr> <td>01/24/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193109" target="_parent">K193109</a></td> <td>MRCAT Brain</td> <td>Philips Medical Systems MR Finland</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>01/17/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192415" target="_parent">K192415</a></td> <td>Study Watch with Irregular Pulse Monitor</td> <td>Verily Life Sciences LLC</td> <td>Cardiovascular</td> <td>DXH</td> </tr> <tr> <td>01/16/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192956" target="_parent">K192956</a></td> <td>Auto Positioning</td> <td>GE Hangwei Medical Systems, Co., Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>01/15/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192004" target="_parent">K192004</a></td> <td>Eko Analysis Software</td> <td>Eko Devices Inc</td> <td>Cardiovascular</td> <td>MWI</td> </tr> <tr> <td>01/15/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191125" target="_parent">K191125</a></td> <td>ADAS 3D</td> <td>Galgo Medical S.L</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/02/2020</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183089" target="_parent">K183089</a></td> <td>Air Next</td> <td>NuvoAir AB</td> <td>Anesthesiology</td> <td>BZG</td> </tr> <tr> <td>12/20/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191647" target="_parent">K191647</a></td> <td>Qlab Advanced Quantification Software</td> <td>Philips Healthcare</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>12/20/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192383" target="_parent">K192383</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>12/17/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192763" target="_parent">K192763</a></td> <td>Syngo.CT CaScoring</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>12/13/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192531" target="_parent">K192531</a></td> <td>QyScore Software</td> <td>Qynapse</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/13/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193170" target="_parent">K193170</a></td> <td>Deep Learning Image Reconstruction</td> <td>GE Healthcare Japan Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>12/13/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192130" target="_parent">K192130</a></td> <td>icobrain</td> <td>icometrix NV</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/11/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192571" target="_parent">K192571</a></td> <td>NemoScan</td> <td>Software Nemotec S.L.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/10/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192287" target="_parent">K192287</a></td> <td>Transpara</td> <td>Screenpoint Medical B.V.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>12/09/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192442" target="_parent">K192442</a></td> <td>FFRangio</td> <td>CathWorks Ltd</td> <td>Cardiovascular</td> <td>QEK</td> </tr> <tr> <td>12/07/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192279" target="_parent">K192279</a></td> <td>PhantomMSK Trauma</td> <td>OrthoGrid Systems Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/27/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192945" target="_parent">K192945</a></td> <td>7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application</td> <td>7D Surgical Inc.</td> <td>Neurology</td> <td>HAW</td> </tr> <tr> <td>11/26/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192320" target="_parent">K192320</a></td> <td>HealthCXR</td> <td>Zebra Medical Vision Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>11/25/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190529" target="_parent">K190529</a></td> <td>SOZO</td> <td>ImpediMed Limited</td> <td>Gastroenterology-Urology</td> <td>QJB</td> </tr> <tr> <td>11/19/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191278" target="_parent">K191278</a></td> <td>RSI-MRI+</td> <td>Multimodal Imaging Services Corporation (Dba HealthLytix)</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/13/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191171" target="_parent">K191171</a></td> <td>EchoGo Core</td> <td>Ultromics Ltd.</td> <td>Radiology</td> <td>QIH</td> </tr> <tr> <td>11/07/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191026" target="_parent">K191026</a></td> <td>MEDIP PRO</td> <td>MEDICAL IP Co., Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/05/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192109" target="_parent">K192109</a></td> <td>Koala</td> <td>IB Lab Gmbh</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/05/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190868" target="_parent">K190868</a></td> <td>Cleerly Labs</td> <td>Cleerly Inc</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/04/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190013" target="_parent">K190013</a></td> <td>WellDoc BlueStar</td> <td>WellDoc, Inc</td> <td>General Hospital</td> <td>MRZ</td> </tr> <tr> <td>11/01/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190334" target="_parent">K190334</a></td> <td>MIMOSA Imager</td> <td>MIMOSA Diagnostics Inc.</td> <td>General and Plastic Surgery</td> <td>MUD</td> </tr> <tr> <td>11/01/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190898" target="_parent">K190898</a></td> <td>Sight OLO</td> <td>Sight Diagnostics Ltd.</td> <td>Hematology</td> <td>GKZ</td> </tr> <tr> <td>10/18/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183274" target="_parent">K183274</a></td> <td>RTHawk, HeartVista Cardiac Package</td> <td>HeartVista, Inc.</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>10/17/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192455" target="_parent">K192455</a></td> <td>Merge PACS</td> <td>Merge Healthcare Incorporated</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/16/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191493" target="_parent">K191493</a></td> <td>Ventripoint Medical System Plus (VMS+) 3.0</td> <td>Ventripoint Diagnostics Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/04/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191994" target="_parent">K191994</a></td> <td>ProFound AI Software V2.1</td> <td>ICAD Inc.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>10/04/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191713" target="_parent">K191713</a></td> <td>CS-Series-FP Radiographic / Fluoroscopic Systems With Optional CA-100S / FluoroShield¿ (ROI Assembly)</td> <td>Omega Medical Imaging, LLC</td> <td>Radiology</td> <td>JAA</td> </tr> <tr> <td>09/18/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192065" target="_parent">K192065</a></td> <td>Syngo.Via RT Image Suite</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>09/16/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191688" target="_parent">K191688</a></td> <td>SubtleMR</td> <td>Subtle Medical Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/13/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192304" target="_parent">K192304</a></td> <td>SIS Software Version 3.6.0</td> <td>Surgical Information Sciences, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/11/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183370" target="_parent">K183370</a></td> <td>PeraMobile and PeraWatch</td> <td>PeraHealth, Inc.</td> <td>Cardiovascular</td> <td>MWI</td> </tr> <tr> <td>09/11/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190815" target="_parent">K190815</a></td> <td>Brainscope TBI</td> <td>BrainScope Company, Inc.</td> <td>Neurology</td> <td>PIW</td> </tr> <tr> <td>09/10/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183268" target="_parent">K183268</a></td> <td>AI-Rad Companion (Cardiovascular)</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>09/04/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191179" target="_parent">K191179</a></td> <td>Myo Plus</td> <td>Otto Bock Healthcare Products GmbH</td> <td>Neurology</td> <td>GXY</td> </tr> <tr> <td>08/29/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183489" target="_parent">K183489</a></td> <td>D2P</td> <td>3D Systems, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/29/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192107" target="_parent">K192107</a></td> <td>Clarius Ultrasound Scanner</td> <td>Clarius Mobile Health Corp.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>08/23/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190593" target="_parent">K190593</a></td> <td>Zio XT ECG Monitoring System, Zio AT ECG Monitoring System</td> <td>iRhythm Technologies, Inc.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>08/15/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183282" target="_parent">K183282</a></td> <td>Biovitals Analytics Engine</td> <td>Biofourmis Singapore Pte. Ltd</td> <td>Cardiovascular</td> <td>PLB</td> </tr> <tr> <td>08/15/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190925" target="_parent">K190925</a></td> <td>HeartfFow FFRct Analysis</td> <td>HeartFlow, Inc.</td> <td>Cardiovascular</td> <td>PJA</td> </tr> <tr> <td>08/12/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183182" target="_parent">K183182</a></td> <td>Critical Care Suite</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>08/05/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191262" target="_parent">K191262</a></td> <td>ABSI</td> <td>EXINI Diagnostics AB</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>07/31/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191183" target="_parent">K191183</a></td> <td>EyeBOX</td> <td>Oculogica, Inc.</td> <td>Neurology</td> <td>QEA</td> </tr> <tr> <td>07/26/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182384" target="_parent">K182384</a></td> <td>ACR | LAB Urine Analysis Test System</td> <td>Healthy.Io Ltd</td> <td>Clinical Chemistry</td> <td>JFY</td> </tr> <tr> <td>07/26/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183271" target="_parent">K183271</a></td> <td>AI-Rad Companion (Pulmonary)</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>07/19/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182798" target="_parent">K182798</a></td> <td>KIDScore D3</td> <td>Vitrolife A/S</td> <td>Obstetrics and Gynecology</td> <td>PBH</td> </tr> <tr> <td>07/18/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191370" target="_parent">K191370</a></td> <td>DreaMed Advisor Pro</td> <td>DreaMed Diabetes Ltd</td> <td>Clinical Chemistry</td> <td>QCC</td> </tr> <tr> <td>07/12/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191585" target="_parent">K191585</a></td> <td>INtuition-Structural Heart Module</td> <td>TeraRecon Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>07/10/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182875" target="_parent">K182875</a></td> <td>DeepCT</td> <td>Deep01 Limited</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>07/10/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183322" target="_parent">K183322</a></td> <td>PhysIQ Heart Rhythm and Respiratory Module</td> <td>PhysIQ, Inc</td> <td>Cardiovascular</td> <td>DPS</td> </tr> <tr> <td>07/08/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191384" target="_parent">K191384</a></td> <td>RayCare 2.3</td> <td>RaySearch Laboratories AB (Publ)</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>07/05/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182901" target="_parent">K182901</a></td> <td>Aquilion Precision (TSX-304A/1 And /2) V8.8 With AiCE</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>07/03/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190442" target="_parent">K190442</a></td> <td>Koios DS For Breast</td> <td>Koios Medical, Inc.</td> <td>Radiology</td> <td>POK</td> </tr> <tr> <td>06/27/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190017" target="_parent">K190017</a></td> <td>Livermultiscan (LMSv3)</td> <td>Perspectum Diagnostics Ltd</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>06/25/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191194" target="_parent">K191194</a></td> <td>CLARUS</td> <td>Carl Zeiss Meditec, Inc</td> <td>Ophthalmic</td> <td>QER</td> </tr> <tr> <td>06/19/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190387" target="_parent">K190387</a></td> <td>Raystation</td> <td>Raysearch Laboratories Ab (Publ)</td> <td>Radiology</td> <td>MUJ</td> </tr> <tr> <td>06/13/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183460" target="_parent">K183460</a></td> <td>ClariCT AI</td> <td>ClariPI Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>06/13/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190424" target="_parent">K190424</a></td> <td>Healthich</td> <td>Zebra Medical Vision Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>06/12/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183046" target="_parent">K183046</a></td> <td>Aquilion ONE (TSX-305A/6) V8.9 With AiCE</td> <td>Canon Medical Systems Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>05/31/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190896" target="_parent">K190896</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>05/24/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191083" target="_parent">K191083</a></td> <td>COMPLETE CONTROL System Gen2</td> <td>Coapt, LLC</td> <td>Neurology</td> <td>GXY</td> </tr> <tr> <td>05/21/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183646" target="_parent">K183646</a></td> <td>Acumen Hypotension Prediction Index - EV1000 Clinical Platform, Acumen Hypotension Prediction Index - Hemosphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index, Hemosphere Advanced Monitoring Platform - Pressure</td> <td>Edwards Lifeciences, LLC</td> <td>Cardiovascular</td> <td>QAQ</td> </tr> <tr> <td>05/15/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183648" target="_parent">K183648</a></td> <td>APAS Independence with Urine Analysis Module</td> <td>Clever Culture Systems AG</td> <td>Microbiology</td> <td>PPU</td> </tr> <tr> <td>05/13/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190764" target="_parent">K190764</a></td> <td>SurgicalAR</td> <td>MEDIVIS, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/06/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190362" target="_parent">K190362</a></td> <td>HealthPNX</td> <td>Zebra Medical Vision Ltd.</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>04/22/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182513" target="_parent">K182513</a></td> <td>FluChip-8G Influenza A+B Assay</td> <td>InDevR, Inc.</td> <td>Microbiology</td> <td>OZE</td> </tr> <tr> <td>04/18/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183593" target="_parent">K183593</a></td> <td>Lung Vision System</td> <td>Body Vision Medical Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/17/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181988" target="_parent">K181988</a></td> <td>EMurmur ID</td> <td>CSD Labs GmbH</td> <td>Cardiovascular</td> <td>DQD</td> </tr> <tr> <td>04/15/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190072" target="_parent">K190072</a></td> <td>Briefcase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>04/12/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183202" target="_parent">K183202</a></td> <td>Deep Learning Image Reconstruction</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>04/08/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183204" target="_parent">K183204</a></td> <td>Bone VCAR (BVCAR)</td> <td>GE Medical Systems SCS</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>03/29/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181352" target="_parent">K181352</a></td> <td>Loop System</td> <td>Spry Health, Inc.</td> <td>Cardiovascular</td> <td>DQA</td> </tr> <tr> <td>03/19/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183019" target="_parent">K183019</a></td> <td>SIS Software Version 3.3.0</td> <td>Surgical Information Sciences, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>03/11/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181823" target="_parent">K181823</a></td> <td>KardiaAI</td> <td>AliveCor, Inc.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>03/08/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183285" target="_parent">K183285</a></td> <td>Cmtriage</td> <td>Curemetrix, Inc</td> <td>Radiology</td> <td>QFM</td> </tr> <tr> <td>03/07/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182344" target="_parent">K182344</a></td> <td>RhythmAnalytics</td> <td>Biofourmis Singapore Pte. Ltd.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>02/16/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183704" target="_parent">K183704</a></td> <td>Rx-1 Rhythm Express Remote Cardiac Monitoring System</td> <td>Vivaquant Inc.</td> <td>Cardiovascular</td> <td>DXH</td> </tr> <tr> <td>02/04/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181916" target="_parent">K181916</a></td> <td>D-Nav System</td> <td>Hygieia, Inc</td> <td>General Hospital</td> <td>NDC</td> </tr> <tr> <td>02/01/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183272" target="_parent">K183272</a></td> <td>AI Rad Companion (Engine)</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/18/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183231" target="_parent">K183231</a></td> <td>SIGNA Premier</td> <td>GE Medical Systems, LLC</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>01/17/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182456" target="_parent">K182456</a></td> <td>Study Watch</td> <td>Verily Life Sciences Llc</td> <td>Cardiovascular</td> <td>DXH</td> </tr> <tr> <td>01/09/2019</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183133" target="_parent">K183133</a></td> <td>MRCP+ V1.0</td> <td>Perspectum Diagnostics Ltd</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/28/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170091" target="_parent">DEN170091</a></td> <td>EyeBOX</td> <td>Oculogica, Inc.</td> <td>Neurology</td> <td>QEA</td> </tr> <tr> <td>12/28/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180867" target="_parent">K180867</a></td> <td>AmCAD-UO</td> <td>AmCad BioMed Corporation</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/27/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182130" target="_parent">K182130</a></td> <td>ISchemaView RAPID</td> <td>ISchemaView, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/27/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182564" target="_parent">K182564</a></td> <td>Quantib ND</td> <td>Quantib BV</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/21/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183012" target="_parent">K183012</a></td> <td>VascuCAP</td> <td>Elucid Bioimaging Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/20/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181861" target="_parent">K181861</a></td> <td>Embrace</td> <td>Empatica Srl</td> <td>Neurology</td> <td>POS</td> </tr> <tr> <td>12/19/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182149" target="_parent">K182149</a></td> <td>FFRangio System</td> <td>CathWorks Ltd</td> <td>Cardiovascular</td> <td>QEK</td> </tr> <tr> <td>12/14/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182419" target="_parent">K182419</a></td> <td>Centricity Universal Viewer</td> <td>GE Healthcare</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/14/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182790" target="_parent">K182790</a></td> <td>Cardio-TriTest v6.5</td> <td>Cardio-Phoenix Inc.</td> <td>Cardiovascular</td> <td>DPS</td> </tr> <tr> <td>12/06/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173749" target="_parent">K173749</a></td> <td>AMRA Profiler</td> <td>AMRA Medical AB</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>12/06/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182373" target="_parent">K182373</a></td> <td>PowerLook Tomo Detection V2 Software</td> <td>ICAD Inc.</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>12/06/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182035" target="_parent">K182035</a></td> <td>FFRct v2.18</td> <td>HeartFlow, Inc.</td> <td>Cardiovascular</td> <td>PJA</td> </tr> <tr> <td>11/30/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182218" target="_parent">K182218</a></td> <td>FerriSmart Analysis System</td> <td>Resonance Health Analysis Service Pty Ltd.</td> <td>Radiology</td> <td>PCS</td> </tr> <tr> <td>11/30/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182336" target="_parent">K182336</a></td> <td>SubtlePET</td> <td>Subtle Medical, Inc.</td> <td>Radiology</td> <td>KPS</td> </tr> <tr> <td>11/29/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182181" target="_parent">K182181</a></td> <td>Persyst 14 EEG Review And Analysis Software</td> <td>Persyst Development Corporation</td> <td>Neurology</td> <td>OMB</td> </tr> <tr> <td>11/21/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181704" target="_parent">K181704</a></td> <td>Transpara</td> <td>Screenpoint Medical Bv</td> <td>Radiology</td> <td>QDQ</td> </tr> <tr> <td>11/20/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181247" target="_parent">K181247</a></td> <td>Vitrea CT Brain Perfusion</td> <td>Vital Images, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/19/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180432" target="_parent">K180432</a></td> <td>AI-ECG Platform</td> <td>Shenzhen Carewell Electronics., Ltd.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>11/16/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180343" target="_parent">K180343</a></td> <td>LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer</td> <td>Bonraybio Co., Ltd.</td> <td>Hematology</td> <td>POV</td> </tr> <tr> <td>11/06/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181939" target="_parent">K181939</a></td> <td>icobrain</td> <td>icometrix NV</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/05/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181288" target="_parent">K181288</a></td> <td>Athelas One</td> <td>Athelas Inc.</td> <td>Hematology</td> <td>GKZ</td> </tr> <tr> <td>11/02/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182616" target="_parent">K182616</a></td> <td>NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System</td> <td>NinePoint Medical, Inc.</td> <td>General and Plastic Surgery</td> <td>NQQ</td> </tr> <tr> <td>10/26/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182177" target="_parent">K182177</a></td> <td>Accipiolx</td> <td>MaxQ-Al Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>10/25/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181685" target="_parent">K181685</a></td> <td>Vivid E80, Vivid E90, Vivid E95</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>10/17/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182034" target="_parent">K182034</a></td> <td>Arterys MICA</td> <td>Arterys Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/09/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181892" target="_parent">K181892</a></td> <td>Ziostation2</td> <td>Ziosoft, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/05/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182112" target="_parent">K182112</a></td> <td>Sense System with IBT Electrodes</td> <td>Infinite Biomedical Technologies, LLC</td> <td>Neurology</td> <td>GXY</td> </tr> <tr> <td>09/28/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173872" target="_parent">K173872</a></td> <td>FibriCheck</td> <td>Qompium NV</td> <td>Cardiovascular</td> <td>DXH</td> </tr> <tr> <td>09/28/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181771" target="_parent">K181771</a></td> <td>RightEye Vision System</td> <td>RightEye, LLC</td> <td>Ophthalmic</td> <td>GWN</td> </tr> <tr> <td>09/21/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182310" target="_parent">K182310</a></td> <td>Volpara Imaging Software</td> <td>Volpara Health Technologies Limited</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/29/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181502" target="_parent">K181502</a></td> <td>Zio AT ECG Monitoring System, Zeus System</td> <td>IRhythm Technologies, Inc.</td> <td>Cardiovascular</td> <td>DQK</td> </tr> <tr> <td>08/01/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180647" target="_parent">K180647</a></td> <td>BriefCase</td> <td>Aidoc Medical, Ltd.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>07/23/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173444" target="_parent">K173444</a></td> <td>Quantitative Total Extensible Imaging (QTxi)</td> <td>AIQ Solutions, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>07/18/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173327" target="_parent">K173327</a></td> <td>DIP/U.S. Urine Analysis Test System</td> <td>Healthy.io Ltd</td> <td>Clinical Chemistry</td> <td>JIL</td> </tr> <tr> <td>07/10/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181572" target="_parent">K181572</a></td> <td>Workflow Box</td> <td>Mirada Medical Ltd.</td> <td>Radiology</td> <td>QKB</td> </tr> <tr> <td>07/10/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181574" target="_parent">K181574</a></td> <td>Uscan</td> <td>EchoNous, Inc.</td> <td>Radiology</td> <td>IYO</td> </tr> <tr> <td>06/29/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180038" target="_parent">K180038</a></td> <td>NuVasive Pulse System</td> <td>NuVasive, Incorporated</td> <td>Orthopedic</td> <td>OLO</td> </tr> <tr> <td>06/26/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173574" target="_parent">K173574</a></td> <td>DenSeeMammo</td> <td>STATLIFE</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>06/14/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173780" target="_parent">K173780</a></td> <td>EchoMD Automated Ejection Fraction Software</td> <td>Bay Labs, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>06/13/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172983" target="_parent">K172983</a></td> <td>HealthCCS</td> <td>Zebra Medical Vision Ltd.</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>06/12/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170043" target="_parent">DEN170043</a></td> <td>DreaMed Advisor Pro</td> <td>DreaMed Diabetes, Ltd.</td> <td>Clinical Chemistry</td> <td>QCC</td> </tr> <tr> <td>06/05/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173821" target="_parent">K173821</a></td> <td>LungQ Software</td> <td>Thirona Corporation</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>05/25/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180163" target="_parent">K180163</a></td> <td>TransEnterix Senhance Surgical System</td> <td>TransEnterix, Inc</td> <td>General and Plastic Surgery</td> <td>NAY</td> </tr> <tr> <td>05/24/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180005" target="_parent">DEN180005</a></td> <td>OsteoDetect</td> <td>Imagen Technologies, Inc.</td> <td>Radiology</td> <td>QBS</td> </tr> <tr> <td>05/14/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173810" target="_parent">K173810</a></td> <td>Ventripoint Medical System Plus (VMS+)</td> <td>Ventripoint Diagnostics, Ltd.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>05/14/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180799" target="_parent">K180799</a></td> <td>Clarius Ultrasound Scanner</td> <td>Clarius Mobile Health Corp.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>05/02/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180599" target="_parent">K180599</a></td> <td>Venue</td> <td>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>05/01/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172959" target="_parent">K172959</a></td> <td>PeraServer and PeraTrend</td> <td>PeraHealth, Inc.</td> <td>Cardiovascular</td> <td>MWI</td> </tr> <tr> <td>04/20/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180161" target="_parent">K180161</a></td> <td>Viz CTP</td> <td>Viz.ai, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/16/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180126" target="_parent">K180126</a></td> <td>SOZO</td> <td>ImpediMed Limited</td> <td>Gastroenterology-Urology</td> <td>OBH</td> </tr> <tr> <td>04/11/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180001" target="_parent">DEN180001</a></td> <td>IDx-DR</td> <td>IDx, LLC</td> <td>Ophthalmic</td> <td>PIB</td> </tr> <tr> <td>04/05/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180589" target="_parent">K180589</a></td> <td>DR 800 With MUSICA Dynamic</td> <td>Agfa HealthCare N.V.</td> <td>Radiology</td> <td>JAA</td> </tr> <tr> <td>03/16/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160044" target="_parent">DEN160044</a></td> <td>Acumen Hypotension Prediction Index (HPI) Feature Software</td> <td>Edwards Lifesciences LLC</td> <td>Cardiovascular</td> <td>QAQ</td> </tr> <tr> <td>03/15/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173839" target="_parent">K173839</a></td> <td>Tissue of Origin Test Kit-FFPE</td> <td>Cancer Genetics, Inc.</td> <td>Pathology</td> <td>OIW</td> </tr> <tr> <td>03/09/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173939" target="_parent">K173939</a></td> <td>Quantib Brain</td> <td>Quantib BV</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>03/08/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173605" target="_parent">K173605</a></td> <td>IQMR</td> <td>Medic Vision - Imaging Solutions Ltd</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/23/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170540" target="_parent">K170540</a></td> <td>DM-Density</td> <td>Densitas, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>02/13/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170073" target="_parent">DEN170073</a></td> <td>ContaCT</td> <td>Viz.Al, Inc.</td> <td>Radiology</td> <td>QAS</td> </tr> <tr> <td>02/08/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180091" target="_parent">K180091</a></td> <td>UNID Spine Analyzer</td> <td>Medicrea International</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/25/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173542" target="_parent">K173542</a></td> <td>Arterys Oncology Dl</td> <td>Arterys Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/12/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173588" target="_parent">K173588</a></td> <td>Illumeo System</td> <td>Philips Medical Systems Technologies, Ltd</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/11/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171122" target="_parent">K171122</a></td> <td>CEREC Ortho Software</td> <td>Dentsply Sirona</td> <td>Dental</td> <td>PNN</td> </tr> <tr> <td>01/08/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171328" target="_parent">K171328</a></td> <td>CNeuro CMRI</td> <td>Combinostics Oy</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/04/2018</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171056" target="_parent">K171056</a></td> <td>WAVE Clinical Platform</td> <td>Excel Medical Electronics, LLC</td> <td>Cardiovascular</td> <td>MWI</td> </tr> <tr> <td>12/27/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173420" target="_parent">K173420</a></td> <td>Radiomics App V1.0</td> <td>Microsoft Corp.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/22/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172507" target="_parent">K172507</a></td> <td>SOZO</td> <td>ImpediMed Limited</td> <td>Cardiovascular</td> <td>DSB</td> </tr> <tr> <td>11/07/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163694" target="_parent">K163694</a></td> <td>Rooti Rx ECG Event Recorder, Rooti Link APP Software</td> <td>Rooti Labs Ltd.</td> <td>Cardiovascular</td> <td>DRG</td> </tr> <tr> <td>10/27/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172803" target="_parent">K172803</a></td> <td>Infinitt PACS 7.0</td> <td>Infinitt Healthcare Co.,Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>10/20/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163623" target="_parent">K163623</a></td> <td>Quantra</td> <td>Hologic, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/27/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171936" target="_parent">K171936</a></td> <td>Peerbridge Cor(TM) System</td> <td>Peerbridge Health Inc.</td> <td>Cardiovascular</td> <td>DSH</td> </tr> <tr> <td>09/15/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172356" target="_parent">K172356</a></td> <td>BladderScan Prime PLUS System</td> <td>Verathon Incorporated</td> <td>Radiology</td> <td>IYO</td> </tr> <tr> <td>09/14/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172385" target="_parent">K172385</a></td> <td>Clarius Ultrasound System</td> <td>Clarius Mobile Health Corp.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>09/07/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170981" target="_parent">K170981</a></td> <td>NeuroQuant</td> <td>CorTechs Labs, Inc</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/17/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163339" target="_parent">K163339</a></td> <td>SpectralMD DeepView Wound Imaging System 2.0</td> <td>SpectralMD, Inc.</td> <td>Cardiovascular</td> <td>DPT</td> </tr> <tr> <td>08/11/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172122" target="_parent">K172122</a></td> <td>SOZO</td> <td>ImpediMed Limited</td> <td>Gastroenterology-Urology</td> <td>OBH</td> </tr> <tr> <td>08/01/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171315" target="_parent">K171315</a></td> <td>Advanced RBC Application</td> <td>Cella Vision AB</td> <td>Hematology</td> <td>JOY</td> </tr> <tr> <td>07/19/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170022" target="_parent">DEN170022</a></td> <td>QuantX</td> <td>Quantitative Insights, Inc</td> <td>Radiology</td> <td>POK</td> </tr> <tr> <td>06/26/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170568" target="_parent">K170568</a></td> <td>CardioLogs ECG Analysis Platform</td> <td>Cardiologs Technologies</td> <td>Cardiovascular</td> <td>DPS</td> </tr> <tr> <td>06/09/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170747" target="_parent">K170747</a></td> <td>Syngo Application Software</td> <td>Siemens Medical Solutions, USA, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>06/07/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170250" target="_parent">K170250</a></td> <td>SmartTarget</td> <td>SmarTarget, Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/24/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170172" target="_parent">K170172</a></td> <td>UNiD Spine Analyzer</td> <td>Medicrea International</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/11/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163622" target="_parent">K163622</a></td> <td>Lung Vision</td> <td>Body Vision Medical Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/05/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163665" target="_parent">K163665</a></td> <td>MATRx Plus</td> <td>Zephyr Sleep Technologies</td> <td>Anesthesiology</td> <td>MNR</td> </tr> <tr> <td>04/26/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170069" target="_parent">K170069</a></td> <td>AmCAD-UV</td> <td>AmCad BioMed Corporation</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/06/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160026" target="_parent">DEN160026</a></td> <td>23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia</td> <td>23andMe, Inc.</td> <td>Hematology</td> <td>PTA</td> </tr> <tr> <td>03/31/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K162627" target="_parent">K162627</a></td> <td>EnsoSleep</td> <td>EnsoData, Inc.</td> <td>Neurology</td> <td>OLZ</td> </tr> <tr> <td>02/23/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K162855" target="_parent">K162855</a></td> <td>Reveal LINQ</td> <td>Medtronic, Inc.</td> <td>Cardiovascular</td> <td>MXD</td> </tr> <tr> <td>02/14/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K162830" target="_parent">K162830</a></td> <td>SIS Software</td> <td>Surgical Information Sciences, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/06/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163013" target="_parent">K163013</a></td> <td>Quantib Brain 1.2</td> <td>Quantib BV</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/05/2017</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163253" target="_parent">K163253</a></td> <td>Arterys Cardio DL</td> <td>Arterys Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/28/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161959" target="_parent">K161959</a></td> <td>ClearView CCAD</td> <td>ClearView Diagnostics Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/07/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161322" target="_parent">K161322</a></td> <td>CT CoPilot</td> <td>Zepmed, LLC</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>11/30/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163138" target="_parent">K163138</a></td> <td>Clarius Ultrasound System</td> <td>Clarius Mobile Health Corp.</td> <td>Radiology</td> <td>IYN</td> </tr> <tr> <td>11/30/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161834" target="_parent">K161834</a></td> <td>One Drop Blood Glucose Monitoring System</td> <td>AgaMatrix Inc.</td> <td>Clinical Chemistry</td> <td>NBW</td> </tr> <tr> <td>11/09/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150043" target="_parent">P150043</a></td> <td>QVCAD System</td> <td>QView Medical, Inc.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>10/19/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K160401" target="_parent">K160401</a></td> <td>Tyto Stethoscope</td> <td>Tyto Care Ltd.</td> <td>Cardiovascular</td> <td>DQD</td> </tr> <tr> <td>09/22/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161068" target="_parent">K161068</a></td> <td>Ahead 300</td> <td>Brainscope Company Inc.</td> <td>Neurology</td> <td>PIW</td> </tr> <tr> <td>09/19/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161625" target="_parent">K161625</a></td> <td>PixelShine</td> <td>AlgoMedica</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/09/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161201" target="_parent">K161201</a></td> <td>ClearRead CT</td> <td>Riverain Technologies, LLC</td> <td>Radiology</td> <td>OEB</td> </tr> <tr> <td>08/24/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161772" target="_parent">K161772</a></td> <td>FFRct v2.0</td> <td>HeartFlow, Inc.</td> <td>Cardiovascular</td> <td>PJA</td> </tr> <tr> <td>08/09/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161148" target="_parent">K161148</a></td> <td>Icobrain</td> <td>Icometrix</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>08/05/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K160338" target="_parent">K160338</a></td> <td>Triton System</td> <td>Gauss Surgical Inc.</td> <td>General and Plastic Surgery</td> <td>PBZ</td> </tr> <tr> <td>07/28/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161382" target="_parent">K161382</a></td> <td>LVivo Software Application</td> <td>DiACardio, Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>07/15/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K160016" target="_parent">K160016</a></td> <td>Steth IO</td> <td>Stratoscientific, Inc.</td> <td>Cardiovascular</td> <td>DQD</td> </tr> <tr> <td>07/07/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K160088" target="_parent">K160088</a></td> <td>Cydar EV</td> <td>Cydar Ltd.</td> <td>Radiology</td> <td>OWB</td> </tr> <tr> <td>06/17/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K153351" target="_parent">K153351</a></td> <td>Quantib Brain 1</td> <td>Quantib BV</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>01/13/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K152733" target="_parent">K152733</a></td> <td>FFRct</td> <td>HeartFlow, Inc.</td> <td>Cardiovascular</td> <td>PJA</td> </tr> <tr> <td>01/07/2016</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K153427" target="_parent">K153427</a></td> <td>Volpara Imaging Software</td> <td>Matakina Technology Ltd.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/21/2015</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K150817" target="_parent">K150817</a></td> <td>Dario Blood Glucose Monitoring System</td> <td>LabStyle Innovations Ltd.</td> <td>Clinical Chemistry</td> <td>NBW</td> </tr> <tr> <td>11/05/2015</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K150102" target="_parent">K150102</a></td> <td>SnoreSounds</td> <td>Appian Medical Inc.</td> <td>Anesthesiology</td> <td>MNR</td> </tr> <tr> <td>06/11/2015</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K142512" target="_parent">K142512</a></td> <td>Personalized Physiology Analytics Engine Software</td> <td>VGBio, Inc. (DBA PhysIQ)</td> <td>Cardiovascular</td> <td>PLB</td> </tr> <tr> <td>05/15/2015</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K143643" target="_parent">K143643</a></td> <td>Brainscope Ahead 200</td> <td>Brainscope Company, Inc.</td> <td>Neurology</td> <td>PIW</td> </tr> <tr> <td>04/24/2015</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K142918" target="_parent">K142918</a></td> <td>EndoTool SubQ</td> <td>Monarch Medical Technologies</td> <td>General Hospital</td> <td>NDC</td> </tr> <tr> <td>02/27/2015</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K141922" target="_parent">K141922</a></td> <td>IRIS Intelligent Retinal Imaging System</td> <td>IRIS Intelligent Retinal Imaging Systems, LLC</td> <td>Ophthalmic</td> <td>NFJ</td> </tr> <tr> <td>11/17/2014</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN140025" target="_parent">DEN140025</a></td> <td>BrainScope Ahead 100</td> <td>BrainScope Company, Inc.</td> <td>Neurology</td> <td>PIW</td> </tr> <tr> <td>10/10/2014</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K142037" target="_parent">K142037</a></td> <td>Quantra</td> <td>Hologic, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/17/2014</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K141069" target="_parent">K141069</a></td> <td>Lung Density Analysis</td> <td>Imbio LLC</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>08/22/2014</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K141480" target="_parent">K141480</a></td> <td>CVI42</td> <td>Circle Cardiovascular Imaging Inc</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>04/22/2014</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K133649" target="_parent">K133649</a></td> <td>Hepatic VCAR</td> <td>GE Medical Systems SCS</td> <td>Radiology</td> <td>JAK</td> </tr> <tr> <td>01/24/2014</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K133259" target="_parent">K133259</a></td> <td>Ysio Max</td> <td>Siemens Medical Solutions USA, Inc.</td> <td>Radiology</td> <td>KPR</td> </tr> <tr> <td>11/21/2013</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K130831" target="_parent">K130831</a></td> <td>MALDI Biotyper CA (MBT-CA) System</td> <td>Bruker Daltonics, Inc.</td> <td>Microbiology</td> <td>PEX</td> </tr> <tr> <td>08/21/2013</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN130013" target="_parent">DEN130013</a></td> <td>Vitek MS</td> <td>Biomerieux, Inc.</td> <td>Microbiology</td> <td>PEX</td> </tr> <tr> <td>03/22/2013</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120771" target="_parent">K120771</a></td> <td>UniCel DxH 800 Coulter Cellular Analysis System</td> <td>Beckman Coulter, Inc.</td> <td>Hematology</td> <td>GKZ</td> </tr> <tr> <td>12/27/2012</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K123526" target="_parent">K123526</a></td> <td>ClearRead +Confirm</td> <td>Riverain Technologies</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>05/17/2012</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120489" target="_parent">K120489</a></td> <td>Tissue of Origin Test Kit FFPE</td> <td>Pathwork Diagnostics, Inc.</td> <td>Pathology</td> <td>OIW</td> </tr> <tr> <td>04/13/2012</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120161" target="_parent">K120161</a></td> <td>AlphaPoint Imaging Software</td> <td>RadLogics, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>12/28/2011</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K111776" target="_parent">K111776</a></td> <td>DeltaView Model 2.1</td> <td>Riverain Medical Group,Llc</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>09/16/2011</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K102778" target="_parent">K102778</a></td> <td>CellaVision® DM1200 with the body fluid application</td> <td>CellaVision AB</td> <td>Hematology</td> <td>JOY</td> </tr> <tr> <td>06/08/2010</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K092967" target="_parent">K092967</a></td> <td>Pathwork Tissue Of Origin Test Kit-Ffpe</td> <td>Pathwork Diagnostics</td> <td>Pathology</td> <td>OIW</td> </tr> <tr> <td>05/12/2010</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K092116" target="_parent">K092116</a></td> <td>EasyCell</td> <td>Medica Corporation</td> <td>Hematology</td> <td>JOY</td> </tr> <tr> <td>12/05/2008</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K080595" target="_parent">K080595</a></td> <td>CellaVision DM96 with the body fluid application</td> <td>Cella Vision AB</td> <td>Hematology</td> <td>JOY</td> </tr> <tr> <td>09/12/2008</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K082483" target="_parent">K082483</a></td> <td>Quantra</td> <td>Hologic, Inc.</td> <td>Radiology</td> <td>LLZ</td> </tr> <tr> <td>07/30/2008</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K080896" target="_parent">K080896</a></td> <td>Pathwork Tissue of Origin Test</td> <td>Pathwork Diagnostics Inc.</td> <td>Pathology</td> <td>OIW</td> </tr> <tr> <td>07/17/2008</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K081140" target="_parent">K081140</a></td> <td>Visensia</td> <td>OBS Medical</td> <td>Cardiovascular</td> <td>MHX</td> </tr> <tr> <td>05/15/2008</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K080762" target="_parent">K080762</a></td> <td>IB Neuro, Version 1.0</td> <td>Imaging Biometrics, LLC</td> <td>Radiology</td> <td>LNH</td> </tr> <tr> <td>10/27/2005</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K043341" target="_parent">K043341</a></td> <td>BioPlex 2200 ANA Screen with Medical Decision Support Software for Use with BioPlex 2200 Multi-Analyte Detection System</td> <td>Bio-Rad Laboratories, Inc.</td> <td>Immunology</td> <td>NVI</td> </tr> <tr> <td>02/10/2004</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K033840" target="_parent">K033840</a></td> <td>CellaVision DM96 Automatic Hematology Analyzer</td> <td>Cella Vision AB</td> <td>Hematology</td> <td>JOY</td> </tr> <tr> <td>03/15/2001</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K003301" target="_parent">K003301</a></td> <td>DiffMaster Octavia Automatic Hematology Analyzer</td> <td>CellaVision AB</td> <td>Hematology</td> <td>JOY</td> </tr> <tr> <td>06/26/1998</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970058" target="_parent">P970058</a></td> <td>M1000 IMAGECHECKER</td> <td>Hologic, Inc.</td> <td>Radiology</td> <td>MYN</td> </tr> <tr> <td>03/11/1997</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K955841" target="_parent">K955841</a></td> <td>Compumedics Sleep Monitoring System</td> <td>Computmedics Sleep Pty. Ltd.</td> <td>Anesthesiology</td> <td>MNR</td> </tr> <tr> <td>11/08/1995</td> <td><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P940029" target="_parent">P940029</a></td> <td>PAPNET Testing System</td> <td>Neuromedical Systems, Inc.</td> <td>Pathology</td> <td>MNM</td> </tr> </tbody> </table> </div> <p>*Non-FDA publicly available resources:</p> <ul> <li><a href="https://ericwu09.github.io/medical-ai-evaluation/">Medical AI Evaluation Database (from “How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals,” Wu, E., et al,  Nature Medicine, 27, 582-584 (2021))</a></li> <li><a href="https://medicalfuturist.com/fda-approved-ai-based-algorithms/">A.I.-based algorithms (The Medical Futurist)</a></li> <li><a href="https://www.statnews.com/wp-content/uploads/2021/02/STAT_FDA_cleared-_AI_tools.xlsx">AI Tools database (STAT) (Excel-22KB) </a></li> <li><a href="https://www.thelancet.com/cms/10.1016/S2589-7500(20)30292-2/attachment/c8457399-f5ce-4a30-8d36-2a9c835fb86d/mmc1.pdf">Supplementary Appendix to “Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20),” Muehlematter UJ, et al., Lancet Digital Health 2021 https://doi.org/10.1016/S2589-7500(20)30292-2. (PDF-856KB)</a></li> <li><a href="https://aicentral.acrdsi.org/">AI Central (American College of Radiology)</a></li> </ul> <p><a name="resources"></a>Note: The FDA has not verified the information that may appear in these resources.</p>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-08-07T00:00:00Z">08/07/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" 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