# Fujifilm Corporaton

- Location (FDA's records): Ashigara Kami-Gun, JP
- FDA decisions: 6 (2020–2023): 6 510(k) clearances
- Product codes: GCJ (2), LLZ (1), EOQ (1), FDS (1), FDA (1)
- 510(k) review time since 2016: median 191 days, against 116 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 10 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fujifilm Corporation: 6 (https://510kreport.com/company/fujifilm)
- Fujifilm Medical System U.S.A., Inc.: 1 (https://510kreport.com/company/fujifilm-medical-system-usa)
- Fujifilm Medical Systems U.S.A, Inc.: 1 (https://510kreport.com/company/fujifilm-medical-systems-usa)

## Firms that cite its devices most
- FUJIFILM Healthcare Americas Corporation: 3 (https://510kreport.com/company/fujifilm-healthcare-americas)
- Fujifilm Corporation: 2 (https://510kreport.com/company/fujifilm)
- Inheart, Sas: 1 (https://510kreport.com/company/inheart)
- Ai Medic, Inc.: 1 (https://510kreport.com/company/ai-medic)
- Schoelly Fiberoptic GmbH: 1 (https://510kreport.com/company/schoelly-fiberoptic)
- Hypervision Surgical: 1 (https://510kreport.com/company/hypervision-surgical)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)

## Its most-cited devices
- K220957: FUJIFILM Endoscope Model EB-710P (2022), cited by 3
- K200973: Synapse 3D Cardiac Tools (2020), cited by 2
- K221551: FUJIFILM Endoscope Model EI-740D/S (2023), cited by 2
- K203717: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 (2021), cited by 2
- K223295: Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (2023), cited by 1

## Recent decisions
- K221551: FUJIFILM Endoscope Model EI-740D/S (Jan 27, 2023)
- K223295: Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (Jan 11, 2023)
- K220957: FUJIFILM Endoscope Model EB-710P (Nov 10, 2022)
- K212950: FUJIFILM Video Laparoscope EL-R740M30 (Dec 2, 2021)
- K203717: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 (Jun 30, 2021)
- K200973: Synapse 3D Cardiac Tools (Aug 27, 2020)

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