# Fujifilm Corporation

- Location (FDA's records): Ashigara Kami-Gun, JP
- FDA decisions: 71 (2018–2026): 71 510(k) clearances
- Product codes: FDS (15), LLZ (6), EOQ (6), FDT (5), FDF (5), ODG (4), LNH (4), FDA (3), MQB (3), FET (3), JAK (3), QNP (2)
- 510(k) review time since 2016: median 128 days, against 130 for FDA's reviews in the same codes and years (27 of 61 faster)
- Predicates its devices cite: 93 (34 its own); citations of its devices by later devices: 52 (34 its own)
- Recalls linked to its devices: 11 (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.: 18 (https://510kreport.com/company/fujifilm-medical-systems-usa)
- Fujifilm Medical System U.S.A., Inc.: 13 (https://510kreport.com/company/fujifilm-medical-system-usa)
- Fujinon, Inc.: 5 (https://510kreport.com/company/fujinon)
- Olympus Medical Systems Corp.: 4 (https://510kreport.com/company/olympus-medical-systems)
- FUJIFILM Healthcare Americas Corporation: 4 (https://510kreport.com/company/fujifilm-healthcare-americas)
- Olympus America, Inc.: 2 (https://510kreport.com/company/olympus-america)
- Fujifilm Corporaton: 2 (https://510kreport.com/company/fujifilm-corporaton)
- Cosmo Artificial Intelligence - Ai, Ltd.: 1 (https://510kreport.com/company/cosmo-artificial-intelligence-ai)

## Firms that cite its devices most
- Fujifilm Corporaton: 6 (https://510kreport.com/company/fujifilm-corporaton)
- Ga Health Company Limited: 3 (https://510kreport.com/company/ga-health)
- FUJIFILM Healthcare Americas Corporation: 3 (https://510kreport.com/company/fujifilm-healthcare-americas)
- Medivators (A Subsidiary of Steris Corporation): 1 (https://510kreport.com/company/medivators-a-subsidiary-of-steris)
- Medsynaptic Private, Ltd.: 1 (https://510kreport.com/company/medsynaptic-private)
- Iq Endoscopes Limited: 1 (https://510kreport.com/company/iq-endoscopes)
- Genoray Co., Ltd.: 1 (https://510kreport.com/company/genoray)
- Intuitive Surgical, Inc.: 1 (https://510kreport.com/company/intuitive-surgical)

## Its most-cited devices
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (2018), cited by 11
- K210162: Endoscope Model EI-740D/S (2021), cited by 3
- K192918: Video Laparoscope, Video Processor, Light Source (2020), cited by 2
- K183032: FUJIFILM Double Balloon Endoscope EI580BT (2019), cited by 2
- K183607: FUJIFILM Bronchoscope (2019), cited by 2
- K221677: Synapse 3D Base Tools v6.6 (2022), cited by 2

## Recent decisions
- K262902: ECHELON Synergy (Oct 9, 2026)
- K261229: SCENARIA View Phase 6.0 (Sep 18, 2026)
- K261283: APERTO Lucent MRI System (Sep 16, 2026)
- K253836: FCT iStream Phase 2 (Sep 4, 2026)
- K261170: BA-004CC (Aug 12, 2026)
- K260567: EW10-EC02 Endoscopy Support Program (Aug 7, 2026)
- K261880: FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 (Jul 2, 2026)
- K253137: FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T (Jun 16, 2026)

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