510(k) K003945 ยท IZH System, X-Ray, Mammographic
OPDIMA
| Applicant | Siemens Medical Solutions USA, Inc., Iselin NJ, US |
| Decision | Substantially Equivalent, Feb 2, 2001 |
| Received | Dec 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003945
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.