510(k) K120246 ยท MUE Full Field Digital, System, X-Ray, Mammographic
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Aug 28, 2012 |
| Received | Jan 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120246
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.