# FUJIFILM Healthcare Americas Corporation

- Location (FDA's records): Lexington, MA
- FDA decisions: 13 (2023–2026): 13 510(k) clearances
- Product codes: FDA (2), JAK (2), QIH (2), LNH (2), FDS (1), EOQ (1), FED (1), ITX (1), IYN (1)
- 510(k) review time since 2016: median 168 days, against 133 for FDA's reviews in the same codes and years (5 of 11 faster)
- Predicates its devices cite: 17 (2 its own); citations of its devices by later devices: 9 (2 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 Corporaton: 3 (https://510kreport.com/company/fujifilm-corporaton)
- Fujifilm Corporation: 3 (https://510kreport.com/company/fujifilm)
- Fujifilm Medical Systems U.S.A, Inc.: 2 (https://510kreport.com/company/fujifilm-medical-systems-usa)
- Fujifilm Healthcare Corporation: 2 (https://510kreport.com/company/fujifilm-healthcare)
- Zutron Medical, LLC: 1 (https://510kreport.com/company/zutron-medical)
- Neptune Medical, Inc.: 1 (https://510kreport.com/company/neptune-medical)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- Hitachi Healthcare Americas: 1 (https://510kreport.com/company/hitachi-healthcare-americas)

## Firms that cite its devices most
- Fujifilm Corporation: 4 (https://510kreport.com/company/fujifilm)
- Olympus Medical Systems Corp.: 2 (https://510kreport.com/company/olympus-medical-systems)
- Fujifilm Healthcare Corporation: 1 (https://510kreport.com/company/fujifilm-healthcare)

## Its most-cited devices
- K231574: Scenaria View 4.2 (2023), cited by 2
- K231666: Endoscopic Ultrasonic Probe  (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (2023), cited by 2
- K232314: Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) (2023), cited by 1
- K230752: Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) (2023), cited by 1
- K243647: Synapse PACS (7.5) (2025), cited by 1
- K233629: APERTO Lucent MRI System (2024), cited by 1

## Recent decisions
- K261713: Synapse PACS (7.6.0) (Jun 18, 2026)
- K251204: FUJIFILM Stiffening Wire Device (SW-2000) (Sep 26, 2025)
- K243647: Synapse PACS (7.5) (Jun 30, 2025)
- K233321: Double Balloon Endoscope  EN-840T, Over-tube TS-1214C (Jun 13, 2024)
- K233629: APERTO Lucent MRI System (May 10, 2024)
- K233687: ECHELON Synergy V10.0 (May 3, 2024)
- K233583: FCT iSTREAM Phase 1 (Apr 26, 2024)
- K240075: FUJIFILM Endoscope Model EB-710XT (Feb 7, 2024)

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