510(k) K991826 ยท IZH System, X-Ray, Mammographic
PLANMED SOPHIE AND SOPHIE CLASSIC
| Applicant | Planmed OY, Wood Dale IL, US |
| Decision | Substantially Equivalent, Aug 10, 1999 |
| Received | May 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991826
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.