510(k) K243341 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Genius AI Detection 2.0
| Applicant | Hologic, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 31, 2025 |
| Received | Oct 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243341
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.