510(k) K133972 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, Mar 25, 2014 |
| Received | Dec 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133972
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2018 | Fujifilm Medical Systems U.S.A., Inc. ASPIRE Cristalle (FDR MS-3500) Mammography machine
The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography image Terminated |
MUE | None listed |
| Aug 4, 2017 | Fujifilm Medical Systems U.S.A., Inc. ASPIRE Cristalle (for FDR-3000AWS)
The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammo Terminated |
MUE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.