510(k) K232147 ยท QHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
CAAS Workstation
| Applicant | Pie Medical Imaging BV, Maastricht, NL |
| Decision | Substantially Equivalent, Apr 9, 2024 |
| Received | Jul 19, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232147
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.