510(k) K211179 ยท QAS Radiological Computer-Assisted Triage And Notification Software
InferRead CT Stroke.AI
| Applicant | Infervision Medical Technology Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Aug 12, 2021 |
| Received | Apr 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211179
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.