510(k) K111646 ยท MUE Full Field Digital, System, X-Ray, Mammographic
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Dec 8, 2011 |
| Received | Jun 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111646
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.