510(k) K240291 ยท QAS Radiological Computer-Assisted Triage And Notification Software
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
| Applicant | Ever Fortune.Ai, Co., Ltd., Taichung City, TW |
| Decision | Substantially Equivalent, Apr 8, 2024 |
| Received | Feb 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240291
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.