# K212873: Aspire Cristalle

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: May 27, 2022 after 260 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: 5 generations back to P030010 (2004). 6 ancestors in all.
1 later device descends 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)
- K173132: ASPIRE Cristalle, Fujifilm Medical Systems U.S.A, Inc. (2017) Summary page 4.

## Most influential descendants
- K243420: Hestia (2025), 0 descendants of its own

## Indications for use
The Fujifilm Digital Mammography System, ASPIRE Ceristalle (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. Dual energy procedures is an optional feature of the ASPIRE Cristalle that can capture images consecutively under two different tube voltage conditions during one compression, and then create and display a subtraction image of the two acquired images. This optional feature shall enable contrast enhanced breast imaging and is used as an adjunct following mammography. Dual energy procedures is not intended for primary screening or diagnosis.

Source page: https://510kreport.com/device/K212873
Methodology: https://510kreport.com/methodology