510(k) K111361 ยท MUE Full Field Digital, System, X-Ray, Mammographic
PLANMED NUANCE EXCEL
| Applicant | Planmeca USA, Inc., Roselle IL, US |
| Decision | Substantially Equivalent, Sep 23, 2011 |
| Received | May 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111361
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.