ASPIRE CRISTALLE— 510(k) K133972
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K133972 for ASPIRE CRISTALLE, Substantially Equivalent on 2014-03-25. 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 K133972
K-number listed on FDA's recall record- Z-0661-2018 — ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) 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-0386-2018 — ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133972.
Data sourced from openFDA. This site is unofficial and independent of the FDA.