510(k) K013656 ยท IZH System, X-Ray, Mammographic
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
| Applicant | Planmed OY, Addison IL, US |
| Decision | Substantially Equivalent, Jan 16, 2002 |
| Received | Nov 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013656
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.