510(k) K251983 ยท QAS Radiological Computer-Assisted Triage And Notification Software
Brainomix 360 Triage Stroke
| Applicant | Brainomix Limited, Oxford, GB |
| Decision | Substantially Equivalent, Aug 26, 2025 |
| Received | Jun 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251983
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.