510(k) K243859 · QIH Automated Radiological Image Processing Software
PRAEVAorta®2
| Applicant | Nurea, Bègles, FR |
| Decision | Substantially Equivalent, Aug 29, 2025 |
| Received | Dec 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243859
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.