# K173132: ASPIRE Cristalle

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Oct 27, 2017 after 28 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P030010 (2004). 5 ancestors in all.
2 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)
- K133972: Aspire Cristalle, Fujifilm Medical Systems U.S.A, Inc. (2014) Summary page 4.

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

## Indications for use
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.

Source page: https://510kreport.com/device/K173132
Methodology: https://510kreport.com/methodology