Chrysalis Intelligence · Sponsors · Fujifilm Corporation

Fujifilm Corporation

Ashigara Kami-Gun, JP · 40 510(k) clearances

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Total clearances
40
2020-02-20 → 2026-08-12
Last 12 months
12
Product codes
20
Most recent
2026-08-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FDS — — — 8 2026-02-17
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Class II Gastroenterology, Urology 3 2026-07-02
EOQ Bronchoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 3 2026-06-16
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Class II Gastroenterology, Urology 3 2022-08-19
QNP Gastrointesinal Lesion Software Detection System Class II Gastroenterology, Urology 2 2026-08-07
QIH Automated Radiological Image Processing Software Class II Radiology 2 2026-04-30
LNH — — — 2 2026-04-06
FDT Duodenoscope And Accessories, Flexible/Rigid Class II Gastroenterology, Urology 2 2026-03-09
FDF — — — 2 2025-05-23
LLZ System, Image Processing, Radiological Class II Radiology 2 2022-11-10
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 2 2020-08-20
ITX — — — 1 2026-08-12
OEB — — — 1 2026-05-27
JAK System, X-Ray, Tomography, Computed Class II Radiology 1 2025-05-20
FED Endoscopic Access Overtube, Gastroenterology-Urology Class II Gastroenterology, Urology 1 2024-11-01
MUE Full Field Digital, System, X-Ray, Mammographic Class II Radiology 1 2022-05-27
KGE Forceps, Biopsy, Electric Class II Gastroenterology, Urology 1 2022-02-04
OWB — — — 1 2021-11-08
FDA Enteroscope And Accessories Class II Gastroenterology, Urology 1 2021-10-29
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Class II Radiology 1 2020-04-10
Filings

All 510(k) clearances (40)

Date K-number Device Code Class Specialty
2026-08-12 K261170 BA-004CC ITX — —
2026-08-07 K260567 EW10-EC02 Endoscopy Support Program QNP Class II Gastroenterology, Urology
2026-07-02 K261880 FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 FET Class II Gastroenterology, Urology
2026-06-16 K253137 FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T EOQ Class II Ear, Nose, Throat
2026-05-27 K254075 Synapse Lung Nodule AI OEB — —
2026-04-30 K254189 Synapse 3D Base Tools (V7.2) QIH Class II Radiology
2026-04-06 K253862 APERTO Lucent MRI System LNH — —
2026-03-09 K251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 FDT Class II Gastroenterology, Urology
2026-02-17 K250550 FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit FDS — —
2026-02-06 K253568 Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR FDS — —
2025-12-12 K250863 FUJIFILM Ultrasonic Endoscope EB-710US EOQ Class II Ear, Nose, Throat
2025-09-17 K251386 ECHELON Synergy LNH — —
2025-06-13 K244017 FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 EOQ Class II Ear, Nose, Throat
2025-06-10 K243512 FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP FDS — —
2025-05-23 K243261 FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L FDF — —
2025-05-21 K243762 Synapse 3D Base Tools (V7.0) QIH Class II Radiology
2025-05-20 K250370 SCENARIA View Phase 5.0 JAK Class II Radiology
2025-04-11 K243260 FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R FET Class II Gastroenterology, Urology
2024-11-01 K243091 Over-tube (TR-1108A) FED Class II Gastroenterology, Urology
2024-10-11 K242779 Hood (DH-083ST) FDS — —
2024-09-04 K240142 FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP FDS — —
2023-12-15 K230751 EW10-EC02 Endoscopy Support Program QNP Class II Gastroenterology, Urology
2023-09-08 K223827 FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 FDF — —
2022-11-10 K221677 Synapse 3D Base Tools v6.6 LLZ Class II Radiology
2022-08-19 K221238 FUJIFILM Ultrasonic Endoscope EG-740UT ODG Class II Gastroenterology, Urology
2022-08-04 K221952 Endoscope Model EG-580UT and Endoscope Model EG-580UR ODG Class II Gastroenterology, Urology
2022-06-03 K214089 FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 ODG Class II Gastroenterology, Urology
2022-05-27 K212873 Aspire Cristalle MUE Class II Radiology
2022-02-04 K220053 Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI KGE Class II Gastroenterology, Urology
2021-11-08 K212956 FDR Cross (DR-XD 3000) OWB — —
2021-10-29 K213195 Balloon BS-3 FDA Class II Gastroenterology, Urology
2021-08-19 K212296 Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 FDS — —
2021-04-09 K210162 Endoscope Model EI-740D/S FDS — —
2021-02-09 K203103 Synapse 3D, Synapse 3D Base Tools v6.1 LLZ Class II Radiology
2020-10-30 K203028 FUJIFILM Distal End Cap FDT Class II Gastroenterology, Urology
2020-08-20 K202130 FUJIFILM Video Laparoscope GCJ Class II Gastroenterology, Urology
2020-07-06 K200850 Fujifilm Ultrasonic Processor FDS — —
2020-05-01 K192286 FUJIFILM EP-6000 Video Processor FET Class II Gastroenterology, Urology
2020-04-10 K200668 DR-ID 1200SDK System MQB Class II Radiology
2020-02-20 K192918 Video Laparoscope, Video Processor, Light Source GCJ Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence