# Fujinon, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 30 (1990–2012): 30 510(k) clearances
- Product codes: GCJ (6), FDS (5), FDF (3), FET (3), EOQ (3), FDA (2), FDT (1), HET (1), FED (1), HIH (1), FBN (1), FWF (1)
- Predicates its devices cite: 22 (14 its own); citations of its devices by later devices: 48 (14 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Marks & Murase: 4 (https://510kreport.com/company/marks-murase)
- Pentax Precision Instrument Corp.: 1 (https://510kreport.com/company/pentax-precision-instrument)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- Hitachi Medical Corp. of America: 1 (https://510kreport.com/company/hitachi-medical-of-america)
- Hitachi Medical Corp.: 1 (https://510kreport.com/company/hitachi-medical)

## Firms that cite its devices most
- Fujifilm Medical Systems U.S.A, Inc.: 6 (https://510kreport.com/company/fujifilm-medical-systems-usa)
- Fujifilm Corporation: 5 (https://510kreport.com/company/fujifilm)
- Fujifilm Medical System U.S.A., Inc.: 4 (https://510kreport.com/company/fujifilm-medical-system-usa)
- Smart Medical Systems, Ltd.: 2 (https://510kreport.com/company/smart-medical-systems)
- Akos Biomedical, Inc.: 2 (https://510kreport.com/company/akos-biomedical)
- Spirus Medical, Inc.: 2 (https://510kreport.com/company/spirus-medical)
- KARL STORZ Endoscopy-America, Inc.: 2 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Del Medical Systems Corp.: 2 (https://510kreport.com/company/del-medical-systems)

## Its most-cited devices
- K040048: Fujinon Double Balloon Enteroscopy System (2004), cited by 10
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 (2009), cited by 7
- K944759: 200 Series Gastro-Intestinal Video System (1995), cited by 4
- K102466: Fujinon Epx-4440HD Digital Video Processor (2011), cited by 4
- K042043: Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5 (2004), cited by 3
- K063316: Fujinon Model EG-530N Trans Nasal Insertion (2007), cited by 3

## Recent decisions
- K120446: Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2 (Aug 13, 2012)
- K112391: Fujinon Colonoscopes (Jul 26, 2012)
- K102466: Fujinon Epx-4440HD Digital Video Processor (May 25, 2011)
- K111243: Fujinon Ultrasonic Processor (May 16, 2011)
- K091773: Fujinon Sterile Overtubes (Aug 7, 2009)
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 (Apr 22, 2009)
- K063316: Fujinon Model EG-530N Trans Nasal Insertion (Mar 16, 2007)
- K063847: Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 (Mar 1, 2007)

Source page: https://510kreport.com/company/fujinon