510(k) K173132 ยท MUE Full Field Digital, System, X-Ray, Mammographic
ASPIRE Cristalle
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Oct 27, 2017 |
| Received | Sep 29, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173132
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.