510(k) K222179 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
Annalise Enterprise CXR Triage Trauma
| Applicant | Annalise-Ai Pty , Ltd., Sydney, AU |
| Decision | Substantially Equivalent, Mar 28, 2023 |
| Received | Jul 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222179
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.