510(k) K243769 ยท QHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
QFR (3.0)
| Applicant | Qfr Solutions BV, Leiden, NL |
| Decision | Substantially Equivalent, Apr 4, 2025 |
| Received | Dec 6, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243769
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.