# Fujifilm New Development U.S.A., Inc.

- Location (FDA's records): Waltham, MA
- FDA decisions: 3 (2017–2018): 3 510(k) clearances
- Product codes: GCJ (2), FET (1)
- 510(k) review time since 2016: median 98 days, against 77 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 2 (1 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 Medical Systems U.S.A, Inc.: 2 (https://510kreport.com/company/fujifilm-medical-systems-usa)
- Applied Medical Resources: 1 (https://510kreport.com/company/applied-medical-resources)
- Fujinon, Inc.: 1 (https://510kreport.com/company/fujinon)

## Firms that cite its devices most
- Fujifilm Corporation: 1 (https://510kreport.com/company/fujifilm)

## Its most-cited devices
- K162836: FUJIFILM Surgical System (2017), cited by 2

## Recent decisions
- K180414: EPX-4440FN Digital Video Processor with Light Source (May 24, 2018)
- K162836: FUJIFILM Surgical System (Mar 13, 2017)
- K170084: InterLock Trocar (Mar 10, 2017)

Source page: https://510kreport.com/company/fujifilm-new-development-usa