510(k) K110729 ยท MUE Full Field Digital, System, X-Ray, Mammographic
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Sep 1, 2011 |
| Received | Mar 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2017 | Fujifilm Medical Systems U.S.A., Inc. Aspire HD (for FDR-1000AWS)
The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems Terminated |
MUE | None listed |
| Jun 9, 2016 | Fujifilm Medical Systems U.S.A., Inc. FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY)
The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammogr Terminated |
MUE | None listed |
| May 6, 2015 | Fujifilm Medical Systems U.S.A., Inc. Aspire HD, Full Field Digital, System, x-Ray, Mammographic;
Model: FOR MS-1000.
A mammography system used for screening and diagnosis of breast cancer. Terminated |
MUE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.