# Fujifilm Healthcare Corporation

- Location (FDA's records): Kashiwa-Shi, JP
- FDA decisions: 6 (2022–2024): 6 510(k) clearances
- Product codes: LNH (4), JAK (1), IYN (1)
- 510(k) review time since 2016: median 126 days, against 115 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hitachi Healthcare Americas: 4 (https://510kreport.com/company/hitachi-healthcare-americas)
- FUJIFILM Healthcare Americas Corporation: 1 (https://510kreport.com/company/fujifilm-healthcare-americas)

## Firms that cite its devices most
- FUJIFILM Healthcare Americas Corporation: 2 (https://510kreport.com/company/fujifilm-healthcare-americas)
- Fujifilm Corporation: 1 (https://510kreport.com/company/fujifilm)

## Its most-cited devices
- K223426: ECHELON Synergy MRI system (2023), cited by 1
- K213829: SCENARIA View (2022), cited by 1
- K241429: ECHELON Synergy MRI System (2024), cited by 1

## Recent decisions
- K241429: ECHELON Synergy MRI System (Aug 13, 2024)
- K240571: OASIS MRI System (Apr 12, 2024)
- K223426: ECHELON Synergy MRI system (Jul 13, 2023)
- K221619: ECHELON Oval V6.2 MRI System (Jan 26, 2023)
- K213829: SCENARIA View (May 23, 2022)
- K220295: Arietta 50 (Apr 29, 2022)

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