510(k) K212783 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
ProstatID
| Applicant | Scanmed, LLC, Omaha NE, US |
| Decision | Substantially Equivalent, Jul 8, 2022 |
| Received | Sep 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212783
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.