510(k) K182317 ยท IZL System, X-Ray, Mobile
AMADEO M-DR mini, AMADEO M-AX mini
| Applicant | Oehm Und Rehbein GmbH, Rostock, DE |
| Decision | Substantially Equivalent, Sep 24, 2018 |
| Received | Aug 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182317
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.