510(k) K243065 ยท QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Cardiac Guidance
| Applicant | Caption Health, Inc., San Mateo CA, US |
| Decision | Substantially Equivalent, Jan 15, 2025 |
| Received | Sep 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243065
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.