510(k) K251610 ยท QAS Radiological Computer-Assisted Triage And Notification Software
qER-CTA (v1.0)
| Applicant | Qure.Ai Technologies, Mumbai, IN |
| Decision | Substantially Equivalent, Sep 8, 2025 |
| Received | May 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251610
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.