510(k) K180019 ยท IZI System, X-Ray, Angiographic
CAAS Workstation
| Applicant | Pie Medical Imaging BV, Maastricht, NL |
| Decision | Substantially Equivalent, May 3, 2018 |
| Received | Jan 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180019
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.