# P050014: Fuji's Computed Radiography  Mammography Suite (Fcrms)

- Pathway: PMA
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Jul 10, 2006 after 467 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K112439: Synapse Workstation Software Version 3.3.0 (2011), 11 descendants of its own
- K160108: Synapse PACS (2016), 8 descendants of its own
- K190232: Synapse PACS (2019), 3 descendants of its own
- K110025: Sectra Microdose Mammography (2011), 3 descendants of its own
- K120255: Philips Microdose (2012), 2 descendants of its own

## Recalls of this device
- Aug 4, 2017 · Class II · Z-0662-2018: 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

Source page: https://510kreport.com/device/P050014
Methodology: https://510kreport.com/methodology