510(k) K213319 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
Viz ANEURYSM, Viz ANX
| Applicant | Viz. Ai, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Feb 18, 2022 |
| Received | Oct 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213319
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.