510(k) DEN210035 · QYV Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
| Applicant | Hologic, Inc., Malborough MA, US |
| Decision | Unknown, Jan 31, 2024 |
| Received | Aug 27, 2021 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN210035
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.