510(k) K162112 ยท LLZ System, Image Processing, Radiological
CAAS MRV
| Applicant | Pie Medical Imaging BV, Maastricht, NL |
| Decision | Substantially Equivalent, Sep 21, 2016 |
| Received | Jul 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162112
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.