“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” is an AI-enabled medical device from Hologic Inc., listed by FDA (De Novo, DEN210035) with a decision date of 2024-01-31. Review panel: Pathology.
| FDA submission number | DEN210035 |
|---|---|
| Pathway | De Novo |
| Company | Hologic Inc. |
| Review panel (specialty) | Pathology |
| FDA decision date | 2024-01-31 |
| Decision | Unknown |
| Product code | QYV |
| Classification | Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm |
| Device class | 2 |
| Regulation number | 864.3900 |
| Review time (calendar days) | 887 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.