DEN210035 is an FDA 510(k) submission for the “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”. This device is classified as a Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm (Class II - Special Controls, product code QYV).
Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Not Cleared (DENG) decision on January 31, 2024.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3900. The Digital Cervical Cytology Slide Imaging System With Artificial Intelligence (ai) Algorithm Is A Prescription In Vitro Diagnostic Device Consisting Of An Automated Digital Slide Creation, Viewing, And Management System Intended To Aid In The Review Of Digital Images Of Slides Prepared From Pap Test Specimens And Conventional Pap Smears By Selecting And Presenting Areas Of Interest To Facilitate Interpretation By The Reader. The Ai Software Algorithm Uses Machine Learning Techniques To Provide Information To The User About The Presence, Location, Or Characteristics Of Areas Of The Image With Clinical Implications. Information From This Device Is Intended To Assist The User In Rendering A Cytology Diagnosis..
| 510(k) Number | DEN210035 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 27, 2021 |
| Decision Date | January 31, 2024 |
| Days to Decision | 887 days |
| Submission Type | Direct |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | QYV — Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.3900 |
| Definition | The Digital Cervical Cytology Slide Imaging System With Artificial Intelligence (ai) Algorithm Is A Prescription In Vitro Diagnostic Device Consisting Of An Automated Digital Slide Creation, Viewing, And Management System Intended To Aid In The Review Of Digital Images Of Slides Prepared From Pap Test Specimens And Conventional Pap Smears By Selecting And Presenting Areas Of Interest To Facilitate Interpretation By The Reader. The Ai Software Algorithm Uses Machine Learning Techniques To Provide Information To The User About The Presence, Location, Or Characteristics Of Areas Of The Image With Clinical Implications. Information From This Device Is Intended To Assist The User In Rendering A Cytology Diagnosis. |