510(k) K111324 ยท MUE Full Field Digital, System, X-Ray, Mammographic
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
| Applicant | Agfa Healthcare N.V., Greenville SC, US |
| Decision | Substantially Equivalent, Dec 22, 2011 |
| Received | May 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111324
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.