510(k) K213941 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
Annalise Enterprise CXR Triage Pneumothorax
| Applicant | Annalise-Ai, Sydney, AU |
| Decision | Substantially Equivalent, Feb 24, 2022 |
| Received | Dec 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213941
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.