510(k) K121963 ยท MUE Full Field Digital, System, X-Ray, Mammographic
PLANMED NUANCE DIGIGUIDE
| Applicant | Planmed OY, Helsinki, FI |
| Decision | Substantially Equivalent, Nov 21, 2012 |
| Received | Jul 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121963
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.