510(k) K211541 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
MammoScreen 2.0
| Applicant | Therapixel, Nice, FR |
| Decision | Substantially Equivalent, Nov 26, 2021 |
| Received | May 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211541
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.