510(k) K231094 ยท QAS Radiological Computer-Assisted Triage And Notification Software
Annalise Enterprise CTB Triage-OH
| Applicant | Annalise-Ai Pty , Ltd., Sydney, AU |
| Decision | Substantially Equivalent, Aug 15, 2023 |
| Received | Apr 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231094
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.