Hologic, Inc. · Class II · Cleared Jan 31, 2024
| K-number | DEN210035 |
| Device name | Genius Digital Diagnostics System with the Genius Cervical AI algorithm |
| Applicant | Hologic, Inc. |
| Product code | QYV |
| Device class | Class II |
| Decision date | Jan 31, 2024 |
| Decision | Not Substantially Equivalent |
| Regulation | 864.3900 |
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