Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042225166

FEI Number

3042225166

Entity Name

FUJIFILM Corporation Medical Systems Research & Development Center Kaisei

City/State/Country

Ashigarakami-Gun Kanagawa, JP

Establishment Address

577, Ushijima, Kaisei-Machi, Ashigarakami-Gun Kanagawa 258-8577, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FUJIFILM CORPORATION (Owner Number: 8031568)

Owner / Operator Contact Address

26-30, Nishiazabu 2-chome, MINATO-KU, JP-13 106-8620, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223827

PMA Number

N/A

All Registered Proprietary Names

Sonosite LX Ultrasound System UHF46-20 Transducer EN-580T TS-12140 Sterile Overtube TS-13101 Sterile Overtube TS-13140 Sterile Overtube Video Laparoscope EL-R740M Endoscope Model EI-740D/S VS-1000 EG-S100XT Over-Tube TS-1314B Tube Kit TY-500D Scope Balloon BS-4 Endoscope Model EN-580T EB-580S Bronchoscope EB-580T Bronchoscope CA-500B Cleaning Adapter Kit for G-5 Bronchoscopes CA-500C Cleaning Adapter Kit CA-500BU Cleaning Adapter Kit for EB-530US Ultrasonic Endoscope EG-580UR Ultrasonic Endoscope EG-580UT FUJIFILM Ultrasonic Processors SU-1 PLATINUM and SU-1 Distal Cap Model DH-17EN2 Distal Cap Model DH-32EN Endoscopic Ultrasonic Probe P2620S-L / P2612S-L BS-2 Balloon for DBE FUJIFILM Endoscope Model EG-840T FUJIFILM Endoscope Model EG-840TP FUJIFILM Endoscope Model EG-840N Ultrasonic Endoscope EB-530US Balloon BS-3 Sonosite MT Ultrasound System Grasping Forceps GF3612RT TRACMOTION EB-710XT Video Bronchoscope EB-530P JT-500 J-Tube EC-740T/L Colonoscope EG-760CT Gastroscope EC-760P-V/L Colonoscope Endoscope Model EI-740D/S CT-2LT LT-100 CT-1LT Distal End Cap DC-08D KE-007D LT-7F LEAKAGE TESTER AW-603 Air/Water Valve SB-604 Suction Valve LMP-001 LAMP ASSEMBLY FOR EPX-2200 LMP-002 LAMP ASSEMBLY FOR EPX-4400/4400HD FV-001 Forceps Valve FOV-LL2 Forceps Valve for EG-530UT2 CA-617 Cleaning Adapter FV-003 Forceps Valve CA-614 Cleaning Adapter ST-05B Single Use Balloon Applicator for DBE BA-BU1 Balloon Attachment Tool for EB-530US AW-602 Air/Water Valve BA-03 Balloon Attachment Tool WA-7000 US Waterproof Cap FV-002 Forceps Valve CC7-301 Cable FOV-DV7 Disposable Forceps Valve Cover for G-5 Endoscopes ST-01B Black Band Applicator for DBE CA-608 Cleaning Adapter BA-1 Balloon Attachment Tool for EG-530UT2 CA-610 Cleaning Adapter AW-500 A-W BUTTON FOR G-5 SCOPES CA-606 Balloon Channel Cleaning Adapter for EN-580T CA-601 Cleaning Adapter Kit for EG-530UR2/UT2 CA-503/A Cleaning Adapter Kit for G-5 Endoscopes ST-10 Setting Tool CA-611 Air/Water Channel Cleaning Adapter CA-510/A Cleaning Adapter Kit /530 Series Endoscopes CA-503B/C Forceps Inlet Cleaning Adapter for G-5 Endoscopes AW-601 Air/Water Button for Ultrasonic Endoscope CA-609 Air/Water Channel Cleaning Adapter SB-605 Suction Valve SB-500 Suction Button for G-5 Scopes SB-601 Suction Button for Ultrasonic Endoscope FUJIFILM Over-tube TR-1504A FUJIFILM Over-tube TR-1507A DH-126STL DH-116STL DH-106STL DH-096ST WB4321FW2 Washing Brush / 4.3mm/2100mm WB11001FW2 Valve Cylinder Washing Brush / 11mm/100mm WB1318DE Single Use Cleaning Brush for Endoscope WB4324FW2 Washing Brush for EN-580T Endoscope WB11003DV Valve Cleaning Brush / 8 to 11mm/63mm WB11002FW2 Valve Cylinder Washing Brush / 11mm/200mm WB7025DC Channel Cleaning Brush / 5.9 to 8mm/2500mm WB2517DC Balloon Channel Cleaning Brush WB3503FW Washing Brush / 3.5mm/300mm WB3512FW Washing Brush / 3.5mm/1200mm WB3212FW2 Washing Brush / 3.2mm/1200mm WB2212FW2 Washing Brush / 2.2/1200mm WB2221FW2 Jet Port Washing Brush for 200/400 Series Endoscopes WB3225DS Washing Brush / 3.5mm/1200mm WB5021FW2 Washing Brush / 5mm/2100mm WB4325DS Washing Brush / 3.5mm/1200mm WB3218FW2 Washing Brush / 3.2mm/1800mm Processor VP-7000 Light Source BL-7000X Image Processing Unit EX-0 CC7-402 CC7-502 DK2623JI FUJIFILM Diathermic Slitter (FlushKnife) DK2620JI FUJIFILM Diathermic Slitter (FlushKnife) TR-1108A MPC-P Mouth Piece MPC-ST Mouth Piece Video Colonoscope EC-760R-V/L Video Colonoscope EC-760ZP-V/L Video Gastroscope EG-760R Video Gastroscope EG-760Z Water Tank WT-603 FUJIFILM Ultrasonic Endoscope EB-710U Double Balloon Endoscope EN-840T FUJIFILM Processor EP-8000 FUJIFILM Endoscope Model EG-860R B20BU Balloon for EB-530US FOV-BU1 Forceps Valve for EB-530US ED-S100TP VS-1000 ED-580XT Duodenoscope FUJIFILM Ultrasonic Processors SU-1 PLATINUM and SU-1 EW10-EC02 Endoscopy Support Program Ultrasonic Probe PB2020-M2 Ultrasonic Processor SP-900 FUJIFILM Endoscope Model EG-840T FUJIFILM Endoscope Model EG-840TP FUJIFILM Endoscope Model EG-840N Gas/Water Valve AW-604G Water Tank WT-04G Gas Tube, CT-11G Fujifilm Endoscopic CO2 Regulator GW-100 Water Tank WT-604G DH-094STR DH-114STR DH-084STR DH-124STR DH-104STR DH-134STR FUJIFILM Video Laparoscope Model EL-R740M30 CA-616 Cleaning Adapter FV--003 Forceps Valve SB-606 Suction Valve EB-710P Bronchoscope Endoscope Model EC-760S-V/L Color Balance Tool CB-01P, CB-01B Fujifilm Diathermic Slitter (FlushKnife) Short Double Balloon Endoscope EI-580BT CP-1TB Trackball Keyboard for Ultrasonic Processors CP-1 Touch-pad Keyboard for Ultrasonic Processors Data Keyboard DK-7000E for VP-7000 and BL-7000 System FS1 Foot Switch for EPX-4440HD Endoscope Model EG-740N BL-7000 EL-R740S FUJIFILM Endoscope Model EC-760S-A/L Endoscopy Support Program EW10-VM01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-07-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-07-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-15
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-03-11
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2019-03-11
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-03-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-08-24
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-04-12
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-04-12
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-02-19
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-02-19
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-01-11
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2023-01-11
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-08-23
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2008-10-02
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-08-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-08-04
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-08-04
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-04-21
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-08-19
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-08-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-12-18
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2013-03-19
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2013-03-19
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-06
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-02-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-02-25
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2021-10-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-11-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-11-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-11-20
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2021-05-21
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-02-09
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2018-01-31
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-03-19
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-07-16
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-07-16
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2023-07-05
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-01-12
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2013-03-07
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-09-16
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-09-06
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-09-06
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2013-03-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-07-01
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2021-07-01
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2021-07-01
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-07-01
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2021-07-01
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2021-07-01
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2022-02-04
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-11-27
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2013-03-20
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-03-09
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-03-09
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-12-18
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2024-06-18
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-04-24
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2025-04-24
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-04-24
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2025-04-24
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2025-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2012-06-18
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2012-06-18
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-03-13
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-03-13
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-07-06
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-07-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-07-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-07-06
QNP	Gastrointesinal Lesion Software Detection System	Gastroenterology, Urology	Class 2	876.1520	2023-12-18
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-06-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-03
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-06-11
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2018-05-25
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-02-09
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-02-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-12-06
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-11-23
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-05-07
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2024-08-12
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2017-11-09
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2019-06-24
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-06-24
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-06-24
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2015-12-21
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-04-02
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2020-02-20
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2020-02-20
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2020-02-20
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-02-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-02-20
QTH	Endoscopic Light-Projecting Measuring Device	Gastroenterology, Urology	Class 2	876.1530	2023-12-07
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

Randy Vader Business: FUJIFILM Healthcare Americas Corporation Email: randy.vader@fujifilm.com Phone: (360) 3566821

Related Public Records

Same Entity

FUJIFILM CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020707080	FUJIFILM medwork GmbH	Hochstadt/Aisch Bavaria, DE
3008787461	FUJIFILM Imaging System (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
2155	FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office	MINAMIASHIGARA-SHI Kanagawa, JP
3005625991	FUJIFILM Healthcare Americas Corporation	Edison, NJ, US
3034364687	FUJIFILM Corporation Material Manufacturing Headquarters	Fujinomiya Shizuoka, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25
K974588	Rimed , Ltd.	INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD	1998-08-07
K142628	Siemens Medi Cal Solutions, Inc.	Acuson SC2000 Diagnostic Ultrasound System	2014-10-10
K132171	Supersonic Imagine	AIXPLORER	2013-09-24
K222441	Bk Medical Aps	Ultrasound System 2300	2022-12-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022	FujiFilm Healthcare Americas Corporation	2	Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024	FUJIFILM Healthcare Americas Corporation	2	Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042225166. Last updated year: 2026. Please use registration number 3042225166 when referencing this establishment in official correspondence.