510(k) Premarket Notification

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title="Database of new or significantly changed device information submitted by medical device manufacturers prior to commercial distribution.">510(k)</A></TD> <TD>|</TD> <TD><A HREF="/scripts/cdrh/cfdocs/cfpmn/denovo.cfm" title="De novo provides a possible route to classify novel devices of low to moderate risk. This database contains de novo classification orders.">DeNovo</A></TD> <TD>|</TD> <TD><A HREF="/scripts/cdrh/cfdocs/cfRL/rl.cfm" title="Database of devices in commercial distribution in the United States submitted by domestic and foreign manufacturers and medical device establishment information submitted by domestic and foreign establishments.">Registration & Listing</A></TD> <TD>|</TD> <TD><A HREF="/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm" title="Reports of adverse events involving medical devices.">Adverse Events</A></TD> <TD>|</TD> <TD><A HREF="/scripts/cdrh/cfdocs/cfRES/res.cfm" title="Database of classified medical device recalls since November 1, 2002.">Recalls</A></TD> <TD>|</TD> <TD><A HREF="/scripts/cdrh/cfdocs/cfPMA/pma.cfm" title="Database of Class III devices that support or sustain human life or are of substantial importance in preventing impairment of human health.">PMA</A></TD> <TD>|</TD> <TD><A HREF="/scripts/cdrh/cfdocs/cfHDE/hde.cfm" title="Humanitaian Device Exemption (HDE) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. 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It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls.">TPLC</A></TD> <TD> </TR> </TABLE> </td> <td align="right" width="15%"> </td> </tr> </table> <br> <br> <table border="0" cellpadding="0" cellspacing="0" width="300" align="center" style="font-family: arial; color: #23238E;"> <TR Valign="top"> <td bgcolor="#888888"> <table border="0" cellpadding="5" cellspacing="1" width="700"> <TR Valign="top"> <td bgcolor="#e9e9e3" width="100%"> <table width="100%" border="0"> <tr> <td align="left"><A style="text-decoration:underline;" href="pmn.cfm">New Search</A></td> <td align="right"><A style="text-decoration:underline;" href="javascript: history.go(-1)">Back To Search Results</A></td> </tr> </table> </td> </tr> <TR Valign="top"> <td bgcolor="#f9f9f3" align="center"> <table border="0" cellpadding="5" cellspacing="5" width="100%" align="center"> <tr> <td align="left" width="100%"> <table align="center" style="text-transform: none"> <tr><th align="left" style="font-family: arial; color: #23238e;">Device Classification Name</th> <td align="left"> <a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&productcode=JAK" title="Products Classification Database Information for System, X-Ray, Tomography, Computed">System, X-Ray, Tomography, Computed</a> </td> </tr> <tr><th align="left">510(k) Number</th> <td align="left">K233749</td></tr> <tr valign="top"><th align="left">Device Name</th> <td align="left">Revolution Ascend Sliding</td></tr> <tr valign="top"> <th align="left">Applicant</th> <td align="left"> <table border="0" cellpadding="0" cellspacing="0" style="text-transform: capitalize"> <tr valign="top"><td align="left">GE Hangwei Medical Systems Co., Ltd.</td></tr> <tr><td align="left">West Area of Building No 3, No.1 Yongchang North Road</td></tr> <tr><td align="left"> Beijing Economic & Technological Develop,  CN 100176 </td></tr> </table> </td></tr> <tr> <th align="left">Applicant Contact</th> <td align="left">Wenqing Tian</td> </tr> <tr valign="top"> <th align="left">Correspondent</th> <td align="left"> <table border="0" cellpadding="0" cellspacing="0" style="text-transform: capitalize"> <tr valign="top"><td align="left">GE Hangwei Medical Systems Co., Ltd.</td></tr> <tr><td align="left">West Area of Building No 3, No.1 Yongchang North Road</td></tr> <tr><td align="left"> Beijing Economic & Technological Develop,  CN 100176 </td></tr> </table> </td></tr> <tr> <th align="left">Correspondent Contact</th> <td align="left">Haibo He</td> </tr> <tr><th align="left">Regulation Number</th><td align="left"><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.1750" title="Code of Federal Regulations (CFR) database information for 892.1750">892.1750</a> </td></tr> <tr valign="top"><th align="left">Classification Product Code</th> <td align="left"> <table border="0" cellpadding="0" cellspacing="0"> <tr> <td align="left"><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&productcode=JAK">JAK</a>  </td> </tr> </table> </td> </tr> <tr><th align="left">Date Received</th><td align="left">11/22/2023</td></tr> <tr><th align="left">Decision Date</th><td align="left"> 02/22/2024</td></tr> <tr><th align="left">Decision</th> <td align="left"> Substantially Equivalent (SESE)</td></tr> <tr><th align="left">Regulation Medical Specialty</th> <td align="left"> Radiology </td></tr> <tr><th align="left">510k Review Panel</th> <td align="left"> Radiology </td></tr> <tr> <th align="left">Summary</th> <td align="left"> <A style="text-decoration:underline;" HREF="https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233749.pdf" TITLE="PDF for K233749" style="text-decoration:underline;">Summary</A> </td> </tr> <tr><th align="left">Type</th><td align="left"> Special </td></tr> <tr><th align="left">Reviewed by Third Party</th> <td align="left"> No </td> </tr> <tr><th align="left">Combination Product</th><td align="left"> No </td></tr> </table> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table>  </span> <div class="clearfloat"> - </div> </div> <div class="clearfloat"> - </div>   <script type="text/javascript"> setStyle(); </script>   <div id="footer">  <div id="footnote"><h4>Links on this page:</h4><div></div></div>   <div id="pagetools_bottom"> <div id="pagetools_right"> <p>Page Last Updated: 11/25/2024</p> <p> Note: If you need help accessing information in different file formats, see <a href="https://www.fda.gov/about-fda/website-policies/viewing-files">Instructions for Downloading Viewers and Players</a>. <br>Language Assistance Available: <a title="Spanish" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#spanish">Español</a> | <a title="Chinese" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#chinese">繁體中文</a> | <a 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