# Fujifilm Medical Systems U.S.A, Inc.

- Location (FDA's records): Stamford, CT
- FDA decisions: 40 (2005–2018): 39 510(k) clearances and 1 original PMA approval
- Product codes: LLZ (13), MQB (6), FDF (5), MUE (3), KGE (2), IZL (2), OTE (1), FDT (1), KPR (1), EOQ (1), FDA (1), FDS (1)
- 510(k) review time since 2016: median 63 days, against 98 for FDA's reviews in the same codes and years (7 of 13 faster)
- Predicates its devices cite: 57 (14 its own); citations of its devices by later devices: 66 (14 its own)
- Recalls linked to its devices: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fujifilm Medical System U.S.A., Inc.: 13 (https://510kreport.com/company/fujifilm-medical-system-usa)
- Fujinon, Inc.: 6 (https://510kreport.com/company/fujinon)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Olympus Medical Systems Corp.: 2 (https://510kreport.com/company/olympus-medical-systems)
- Marks & Murase: 1 (https://510kreport.com/company/marks-murase)
- Barcoview Mis Edinburgh: 1 (https://510kreport.com/company/barcoview-mis-edinburgh)
- Ziosoft, Inc.: 1 (https://510kreport.com/company/ziosoft)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Firms that cite its devices most
- Fujifilm Corporation: 18 (https://510kreport.com/company/fujifilm)
- Fujifilm Medical System U.S.A., Inc.: 11 (https://510kreport.com/company/fujifilm-medical-system-usa)
- FUJIFILM Healthcare Americas Corporation: 2 (https://510kreport.com/company/fujifilm-healthcare-americas)
- Fujifilm New Development U.S.A., Inc.: 2 (https://510kreport.com/company/fujifilm-new-development-usa)
- Virtual Radiologic Corporation: 2 (https://510kreport.com/company/virtual-radiologic)
- Touch Medical Solutions, Inc.: 1 (https://510kreport.com/company/touch-medical-solutions)
- Samsung Electronics Co., Ltd.: 1 (https://510kreport.com/company/samsung-electronics)
- Aspyra, Inc.: 1 (https://510kreport.com/company/aspyra)

## Its most-cited devices
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (2015), cited by 7
- K051553: Fuji Synapse Workstation Software (2005), cited by 6
- K162749: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (2017), cited by 5
- K132210: Fujifilm 600 Series Endoscopes (2014), cited by 4
- K061672: Synapse Mip/MPR Image Visualization Software Obliquus (2006), cited by 4
- K120361: Synapse 3D Base Tools (2012), cited by 4

## Recent decisions
- K171291: FUJIFILM Bronchoscope Model EB-530P (Jan 19, 2018)
- K171207: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (Jan 11, 2018)
- K173132: ASPIRE Cristalle (Oct 27, 2017)
- K171463: ASPIRE Bellus II (Sep 29, 2017)
- K152257: Fujifilm Duodenoscope Model ED-530XT (Jul 21, 2017)
- K163624: Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) (Jun 30, 2017)
- K162749: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (Jun 15, 2017)
- K171096: Fujifilm Diathermic Slitter (FlushKnife) (May 9, 2017)

Source page: https://510kreport.com/company/fujifilm-medical-systems-usa