De Novo Classifications
FDA submissions for De Novo Classifications in the Pathology (PA) review panel, including product codes, regulations, and recent device decisions.
Section range: § 864.3900
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| QYV | Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm | 864.3900 | 2 | 1 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| DEN210035 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm | Hologic, Inc. | Jan 31, 2024 |
