510(k) K021945 ยท IZH System, X-Ray, Mammographic
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
| Applicant | Planmed OY, Roselle IL, US |
| Decision | Substantially Equivalent, Feb 21, 2003 |
| Received | Jun 13, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021945
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.