510(k) K203822 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
ProFound AI Software V3.0
| Applicant | Icad, Inc., Nashua NH, US |
| Decision | Substantially Equivalent, Mar 12, 2021 |
| Received | Dec 29, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203822
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.