510(k) K243684 ยท QIH Automated Radiological Image Processing Software
BrightHeart View Classifier
| Applicant | Brightheart, Paris, FR |
| Decision | Substantially Equivalent, May 7, 2025 |
| Received | Nov 29, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243684
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.