DEN210035
- 510(k) number
- DEN210035
- Device name
- Genius Digital Diagnostics System with the Genius Cervical AI algorithm
- Applicant
- Hologic, Inc. MA · US
- Product code
- QYV — Digital Cervical Cytology Slide Imaging System With
- Decision date
- 2024-01-31
- Date received
- 2021-08-27
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Pathology
Official FDA record: DEN210035
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.