510(k) K240353 ยท QAS Radiological Computer-Assisted Triage And Notification Software
Hyper Insight - ICH
| Applicant | Sk, Inc., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Jul 1, 2024 |
| Received | Feb 5, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240353
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.