510(k) K113284 ยท IZH System, X-Ray, Mammographic
BIOPSY POSITIONER
| Applicant | Fuji Film Medical Systems, Stamford CT, US |
| Decision | Substantially Equivalent, Mar 7, 2012 |
| Received | Nov 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113284
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.