510(k) K212261 ยท QAS Radiological Computer-Assisted Triage And Notification Software
StrokeSENS LVO
| Applicant | Circle Neurovascular Imaging, Inc., Calgary, CA |
| Decision | Substantially Equivalent, Oct 14, 2021 |
| Received | Jul 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212261
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.