# Fujifilm Medical System U.S.A., Inc.

- Location (FDA's records): Stamford, CT
- FDA decisions: 72 (1988–2017): 71 510(k) clearances and 1 original PMA approval
- Product codes: LLZ (19), MQB (10), LMC (7), EAM (7), IXK (4), IXW (4), MUE (3), KPR (3), IXA (2), FET (2), FDS (2), EOQ (2)
- Predicates its devices cite: 59 (20 its own); citations of its devices by later devices: 84 (20 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fujifilm Medical Systems U.S.A, Inc.: 11 (https://510kreport.com/company/fujifilm-medical-systems-usa)
- Olympus Medical Systems Corp.: 4 (https://510kreport.com/company/olympus-medical-systems)
- Fujinon, Inc.: 4 (https://510kreport.com/company/fujinon)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Vida Diagnostics, Inc.: 2 (https://510kreport.com/company/vida-diagnostics)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Canon Inc. -Medical Equipment Group: 1 (https://510kreport.com/company/canon-medical-equipment-group)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Firms that cite its devices most
- Fujifilm Corporation: 13 (https://510kreport.com/company/fujifilm)
- Fujifilm Medical Systems U.S.A, Inc.: 13 (https://510kreport.com/company/fujifilm-medical-systems-usa)
- Shimadzu Corp.: 8 (https://510kreport.com/company/shimadzu)
- Konica Minolta Medical & Graphic, Inc.: 3 (https://510kreport.com/company/konica-minolta-medical-graphic)
- Aspyra, Inc.: 2 (https://510kreport.com/company/aspyra)
- Denoptix, Inc.: 2 (https://510kreport.com/company/denoptix)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)
- Virtual Radiologic Corporation: 1 (https://510kreport.com/company/virtual-radiologic)

## Its most-cited devices
- K041990: Fuji Medical CR Console, Model Flash Iip (2004), cited by 6
- K142003: FDR D-Evo II Flat Panel Detector System (2014), cited by 6
- K163675: Processor VP-7000, Light Source BL-7000 (2017), cited by 5
- K951373: Fuji Computed Radiography System FCR9000HQ, FCR9501HQ (1995), cited by 5
- K993861: Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side Reader (2000), cited by 3
- P050014: Fuji's Computed Radiography  Mammography Suite (Fcrms) (2006), cited by 3

## Recent decisions
- K163675: Processor VP-7000, Light Source BL-7000 (Apr 25, 2017)
- K153206: Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 (Mar 3, 2016)
- K151474: Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) (Feb 18, 2016)
- K152138: FDR D-EVO GL Flat Panel Detector System (Nov 5, 2015)
- K150221: EPX-4440HD and EPX-4400HD with FICE (Oct 1, 2015)
- K142629: EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (May 14, 2015)
- K142003: FDR D-Evo II Flat Panel Detector System (Oct 21, 2014)
- K133976: Fujifilm Endoscopic CO2 Regulator (Sep 9, 2014)

Source page: https://510kreport.com/company/fujifilm-medical-system-usa