510(k) K231384 ยท QAS Radiological Computer-Assisted Triage And Notification Software
Annalise Enterprise CTB Triage Trauma
| Applicant | Annalise-Ai Pty , Ltd., Sydney, AU |
| Decision | Substantially Equivalent, Sep 22, 2023 |
| Received | May 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231384
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.