ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM— 510(k) K110729
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K110729 for ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM, Substantially Equivalent on 2011-09-01. Applicant: Fujifilm Medical Systems U.S.A, Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Product code
- Code MUE
- Device class
- Class 2
- Regulation
- 21 CFR 892.1715
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code MUE
view allMore clearances from Fujifilm Medical Systems U.S.A, Inc.
view allAdverse events under product code MUE
product code MUE- Death
- 5
- Other
- 1
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110729
K-number listed on FDA's recall record- Z-0659-2018 — 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, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
- Z-2690-2016 — 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 mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
- Z-1585-2015 — Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110729.
Data sourced from openFDA. This site is unofficial and independent of the FDA.