510(k) K230074 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
Rapid Aneurysm Triage and Notification
| Applicant | Ischemaview, Inc., Golden CO, US |
| Decision | Substantially Equivalent, Jul 27, 2023 |
| Received | Jan 10, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230074
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.