510(k) K193087 ยท QAS Radiological Computer-Assisted Triage And Notification Software
Rapid ICH
| Applicant | Ischemaview Incorporated, Golden CO, US |
| Decision | Substantially Equivalent, Mar 31, 2020 |
| Received | Nov 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193087
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.