Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003775006

FEI Number

3003775006

Entity Name

FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office

City/State/Country

HANAMAKI-SHI Iwate, JP

Establishment Address

2-1-3 KITAYUGUCHI, HANAMAKI-SHI Iwate 025-0301, 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

K202130

PMA Number

N/A

All Registered Proprietary Names

FDR D-EVO III G35 (DR-ID 1801SE) FDR D-EVO III G43 (DR-ID 1802SE) FDR D-EVO III Flat Panel Detector System (DR-ID 1800) FDR D-EVOIII G35i (DR-ID 1831SE) FDR D-EVOIII C25i (DR-ID 1814SE) FDR D-EVOIII C43i (DR-ID 1812SE) FDR D-EVOIII C35i (DR-ID 1811SE) FDR D-EVOIII G43i (DR-ID 1832SE) FDR D-EVOIII G80i (DR-ID 1836SE) FDR D-EVO II G35 (DR-ID1201SE) FDR D-EVO II G43 (DR-ID1202SE) FDR ES G35 (DR-ID1271SE) FDR D-EVO II (DR-ID1200) FDR D-EVO II Flat Panel Detector System (DR-ID1200) FDR ES C43 (DR-ID1274SE) FDR ES(DR-ID 1270) FDR ES C35 (DR-ID1273SE) FDR ES G43 (DR-ID127SE) FDR D-EVO II C43 (DR-ID 1212SE) FDR D-EVO II C35 (DR-ID 1211SE) FDR D-EVO II C24 (DR-ID 1213SE) FDR ES II C25 DR-ID 1280 DR-ID 1284SE DR-ID 1282SE FDR ES II G43 FDR ES II C35 FDR ES II G35 FDR ES II C43 DR-ID 1283SE DR-ID 1285SE FDR ES II (DR-ID 1280) DR-ID 1281SE FDR D-EVO with X-ray Detection Feature ASPIRE Cristalle Digital Breast Tomosynthesis Option AMULET Innovality Digital Breast Tomosynthesis Option FDR AQRO (DR-XD 1000) FUJIFILM Video Laparoscope Model EL-R740M30 Synapse 3D Base Tools V7 Remote Switch: RC-30 Balloon Controller: PB-30 Gas Tube, CT-11G Water Tank WT-04G Fujifilm Endoscopic CO2 Regulator GW-100 Biopsy Positioner FDR-2000BPY Aspire Cristalle FDR MS-3500 Video Colonoscope EC-760R-V/L Video Colonoscope EC-760ZP-V/L Video Gastroscope EG-760R Video Gastroscope EG-760Z Water Tank WT-603 ASPIRE Cristalle DR-ID1200MC FDR D-EVO GL Flat Panel Detector System (DR-ID 1300) FDR D-EVO GL (DR-ID1305SE) DR-ID1300MP Fujifilm WT-4 Water Tank Synapse 3D Base Tools V6.6 Aspire Cristalle (DVIIm) FCR 1 Shot Phantom Plus FDR CROSS (DR-XD 3000) FDR D-EVO Mobile Compo (DR-ID800) Gas/Water Valve AW-604G Water Tank WT-04G Gas Tube, CT-11G Fujifilm Endoscopic CO2 Regulator GW-100 Water Tank WT-604G DR-ID 1200SDK System FUJIFILM Tomosynthesis Option for FDR AcSelerate Stationary X-ray System CT-2LT LT-100 CT-1LT FUJIFILM FDR Dual Energy Subtraction Option (DES) 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 EW10-EC02 Endoscopy Support Program BL-7000 EL-R740S Synapse 3D Base Tools (V7.2) Video Laparoscope EL-R740M

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-11-13
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2014-11-13
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2012-08-31
OTE	Digital Breast Tomosynthesis	Unknown	Class 3	N/A	2017-01-17
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2017-05-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-12-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-05-22
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-05-22
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2015-12-18
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-12-18
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2014-11-20
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2019-07-04
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2014-03-28
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
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2022-05-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2015-11-16
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-05-27
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-05-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-11-23
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2018-01-04
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2006-10-25
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-11-09
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-11-09
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2011-09-14
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2018-05-25
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-04-10
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2013-01-30
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2023-07-05
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2013-01-30
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2015-12-21
QNP	Gastrointesinal Lesion Software Detection System	Gastroenterology, Urology	Class 2	876.1520	2023-12-18
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
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-05-08
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-05-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-08-24

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
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-2219-2025	FUJIFILM Healthcare Americas Corporation	3	ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003775006. Last updated year: 2026. Please use registration number 3003775006 when referencing this establishment in official correspondence.