510(k) K182611 ยท QHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Qangio XA 3D
| Applicant | Medis Medical Imaging Systems BV, Leiden, NL |
| Decision | Substantially Equivalent, May 30, 2019 |
| Received | Sep 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182611
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.