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Product Classification

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Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.</td> </tr> <tr valign="top"> <th align="left" nowrap>Physical State</th> <td align="left" class="hardbreak">Software application and/or firmware, system components and accessories</td> </tr> <tr valign="top"> <th align="left" nowrap>Technical Method</th> <td align="left" class="hardbreak">Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.</td> </tr> <tr valign="top"> <th align="left" nowrap>Target Area</th> <td align="left" class="hardbreak">Human-derived imaging products</td> </tr> <tr> <th align="left">Regulation Medical Specialty</th> <td align="left">Radiology</td> </tr> <tr><th align="left">Review Panel</th> <td align="left"> Radiology </td> </tr> <tr><th align="left" nowrap>Product Code</th><td align="left">QIH</td></tr> <tr valign="top"> <th align="left" nowrap>Premarket Review</th> <td align="left"> <A style="text-decoration:underline;" href="https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-organization#OHT8">Office of Radiological Health</A> (OHT8)<br> Radiological Imaging Devices and Electronic Products (DHT8B)<br> </td> </tr> <tr><th align="left" nowrap>Submission Type</th> <td align="left"> 510(k) </td></tr> <tr><th align="left" nowrap>Regulation Number</th> <td align="left"> <a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.2050" title="information about 21cfr892.2050">892.2050</a> </td> </tr> <tr> <th align="left" nowrap>Device Class</th> <td align="left"> 2 </td> </tr> <tr> <th align="left" nowrap>Total Product Life Cycle (TPLC)</th> <td align="left"> <A style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=5827">TPLC Product Code Report</A> </td> </tr> <tr> <th align="left" nowrap>GMP Exempt?</th> <td align="left">No </td> </tr> <tr> <th align="left" nowrap>Summary Malfunction<br>Reporting</th> <td align="left">Ineligible</td> </tr> <tr><th align="left" nowrap>Implanted Device? </th><td align="left"> No </td></tr> <tr><th align="left" nowrap>Life-Sustain/Support Device? </th><td align="left"> No </td></tr> <tr> <td valign="top" align="left"><b>Third Party Review</b></td> <td valign="top" align="left">Not Third Party Eligible</td> </tr> </tbody> </table> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <!-- ******** end database content ******** --> </span> <div class="clearfloat"> - </div> </div> <div class="clearfloat"> - </div> <!--mp_trans_add <blockquote> <hr> <p>This website has been translated to Spanish from English, and is updated often. 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