Medical Device Manufacturer · JP , Ashigara Kami-Gun

Fujifilm Corporation

60 submissions · 60 cleared · Since 2018
60
Total
60
Cleared
0
Denied

Fujifilm Corporation — FDA 510(k) Submissions

Fujifilm Corporation has submitted 60 FDA 510(k) premarket notifications since 2018, of which 60 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Gastroscope And Accessories, Flexible/rigid, System, Image Processing, Radiological, Colonoscope And Accessories, Flexible/rigid, Duodenoscope And Accessories, Flexible/rigid, Bronchoscope (flexible Or Rigid) . Use the specialty filter in the sidebar to narrow results.

60 devices
1–25 of 60
FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
K251861 · FDT Duodenoscope And... · Gastroenterology & Urology
Mar 2026 265d
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
K250550 · FDS Gastroscope And... · Gastroenterology & Urology
Feb 2026 357d
Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
K253568 · FDS Gastroscope And... · Gastroenterology & Urology
Feb 2026 81d
FUJIFILM Ultrasonic Endoscope EB-710US
K250863 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Dec 2025 266d
ECHELON Synergy
K251386 · LNH System, Nuclear Magnetic... · Radiology
Sep 2025 135d
FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000
K244017 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Jun 2025 168d
FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
K243512 · FDS Gastroscope And... · Gastroenterology & Urology
Jun 2025 210d
FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
K243261 · FDF Colonoscope And... · Gastroenterology & Urology
May 2025 220d
Synapse 3D Base Tools (V7.0)
K243762 · QIH Automated Radiological... · Radiology
May 2025 166d
SCENARIA View Phase 5.0
K250370 · JAK System, X-ray,... · Radiology
May 2025 99d
FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
K243260 · FET Endoscopic Video Imaging... · Gastroenterology & Urology
Apr 2025 178d
Over-tube (TR-1108A)
K243091 · FED Endoscopic Access... · Gastroenterology & Urology
Nov 2024 32d
Hood (DH-083ST)
K242779 · FDS Gastroscope And... · Gastroenterology & Urology
Oct 2024 28d
FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
K240142 · FDS Gastroscope And... · Gastroenterology & Urology
Sep 2024 230d
EW10-EC02 Endoscopy Support Program
K230751 · QNP Gastrointesinal Lesion... · Gastroenterology & Urology
Dec 2023 273d
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
K223827 · FDF Colonoscope And... · Gastroenterology & Urology
Sep 2023 261d
Synapse 3D Base Tools v6.6
K221677 · LLZ System, Image Processing,... · Radiology
Nov 2022 154d
FUJIFILM Ultrasonic Endoscope EG-740UT
K221238 · ODG Endoscopic Ultrasound... · Gastroenterology & Urology
Aug 2022 112d
Endoscope Model EG-580UT and Endoscope Model EG-580UR
K221952 · ODG Endoscopic Ultrasound... · Gastroenterology & Urology
Aug 2022 30d
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
K214089 · ODG Endoscopic Ultrasound... · Radiology
Jun 2022 157d
Aspire Cristalle
K212873 · MUE Full Field Digital,... · Radiology
May 2022 260d
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K220053 · KGE Forceps, Biopsy, Electric · Gastroenterology & Urology
Feb 2022 29d
FDR Cross (DR-XD 3000)
K212956 · OWB Interventional... · Radiology
Nov 2021 53d
Balloon BS-3
K213195 · FDA Enteroscope And Accessories · Gastroenterology & Urology
Oct 2021 30d
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
K212296 · FDS Gastroscope And... · Gastroenterology & Urology
Aug 2021 28d
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