510(k) K211431 ยท QIH Automated Radiological Image Processing Software
breastscape v1.0
| Applicant | Olea Medical, La Ciotat, FR |
| Decision | Substantially Equivalent, Aug 2, 2021 |
| Received | May 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211431
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.