ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM — Fujifilm Medical Systems U.S.A, Inc. (510(k) K110729)
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM — Fujifilm Medical Systems U.S.A, Inc. (510(k) K110729) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM; Applicant: Fujifilm Medical Systems U.S.A, Inc.; Clearance track: 510(k).
| Device name | ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM |
|---|---|
| Applicant | Fujifilm Medical Systems U.S.A, Inc. |
| Clearance track | 510(k) |
| Submission number | K110729 |
| Decision | Substantially Equivalent |
| Decision date | 2011-09-01 |
| Date received | 2011-03-16 |
| Product code | MUE |
| Device class | 2 |
| Medical specialty | Radiology |
| Applicant location | CT, US |
| Source | openFDA device |
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