510(k) K121674 ยท MUE Full Field Digital, System, X-Ray, Mammographic
ASPIRE HD PLUS, ASPIRE HD-S
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Sep 21, 2012 |
| Received | Jun 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121674
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2018 | Fujifilm Medical Systems U.S.A., Inc. Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000),
also known as Aspire HD Plus S). Mammography machine
The Fujifilm Digital Mammography Systems, Aspire HD Terminated |
MUE | None listed |
| Aug 4, 2017 | Fujifilm Medical Systems U.S.A., Inc. Aspire HD Plus, Aspire HD-s (for FDR-2000AWS)
The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images tha Terminated |
MUE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.