Device Classification Under Section 513(f)(2)(De Novo)

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align="center" style="text-transform: capitalize; table-layout:fixed; width:500px"> <tr><th align="left" style="font-family: arial; color: #23238e;">Device Classification Name</th> <td align="left" class="wrapword"> <a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&productcode=QVD" title="Products Classification Database Information for Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan">radiological machine learning based quantitative imaging software with change control plan</a> </td> </tr> <tr><th align="left">De Novo Number</th> <td align="left">DEN220063</td></tr> <tr valign="top"><th align="left">Device Name</th> <td align="left" class="wrapword">Caption Interpretation Automated Ejection Fraction Software</td></tr> <tr valign="top"> <th align="left">Requester</th> <td align="left"> <table border="0" cellpadding="0" cellspacing="0" style="text-transform: capitalize"> <tr valign="top"><td align="left" >caption health, inc</td></tr> <tr><td align="left">2000 sierra point parkway, 8th floor</td></tr> <tr><td align="left"> brisbane,  CA  94005 </td></tr> </table> </td></tr> <tr> <th align="left">Contact</th> <td align="left">tahir rizvi</td> </tr> <tr><td align="left"> </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=892.2055" title="Code of Federal Regulations (CFR) database information for 892.2055">892.2055</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=QVD">QVD</a>  </td> </tr> </table> </td> </tr> <tr><th align="left">Date Received</th><td align="left">09/28/2022</td></tr> <tr><th align="left">Decision Date</th><td align="left"> 02/24/2023</td></tr> <tr><th align="left">Decision</th> <td align="left"> granted (DENG)</td></tr> <tr><th align="left">Classification Advisory Committee</th> <td align="left"> Radiology </td></tr> <tr><th align="left">Review Advisory Committee</th> <td align="left"> Radiology </td></tr> <tr> <th align="left">Classification Order</th> <td align="left"> <A style="text-decoration:underline;" HREF="https://www.accessdata.fda.gov/cdrh_docs/pdf22/DEN220063.pdf" TITLE="PDF for DEN220063" style="text-decoration:underline;">Classification Order</A> </td> </tr> <tr><th align="left">FDA Review</th> <td align="left"><a style="text-decoration:underline;" href="http://www.accessdata.fda.gov/cdrh_docs/reviews/DEN220063.pdf" title="pdf of 510(k) DEN220063">Decision Summary</a> </td> </tr> <tr><th align="left">Type</th><td align="left"> Direct </td></tr> </table> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table>  </span> <div class="clearfloat"> - </div> </div> <div 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