# K133972: Aspire Cristalle

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Mar 25, 2014 after 89 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P030010 (2004). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121674: Aspire HD Plus, Aspire HD-S, Fujifilm Medical System U.S.A., Inc. (2012) Summary page 1.

## Most influential descendants
- K173132: ASPIRE Cristalle (2017), 2 descendants of its own
- K212873: Aspire Cristalle (2022), 1 descendant of its own
- K243420: Hestia (2025), 0 descendants of its own

## Recalls of this device
- Aug 4, 2017 · Class II · Z-0661-2018: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a uni
- Jul 14, 2017 · Class II · Z-0386-2018: There was a case that the swivel arm went down unintentionally when it was moved up/down.

## Indications for use
The Fujifilm Digital Mammography System, ASPIRE Cristalle (EDR 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.

Source page: https://510kreport.com/device/K133972
Methodology: https://510kreport.com/methodology