# K111646: Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General Radiography, Reader IS Carbon XL2/FCR

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Dec 8, 2011 after 178 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: 1 generation back to P080018 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P080018: Kodak Directview Computed Radiography (CR) Mammography, Carestream Health, Inc. (2010) Summary page 5.
- (no number) Fuji CR for Mammography System (FCRMS): named in the summary without a submission number

## Indications for use
The Aspire CR for Mammography (GRin) System is indicated for generating mamnmographic images that can be used for screening and diagnosis of breast cancer. The Fuji Aspire GRin System is intended to be used in the same clinical applications as traditional film/screen systems.

Source page: https://510kreport.com/device/K111646
Methodology: https://510kreport.com/methodology