FUJIFILM CORPORATION

FDA Device Registration & Listing · ASHIGARAKAMI-GUN Kanagawa, JP · Registration 3001722928

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3001722928
FEI Number
3001722928
Entity Name
FUJIFILM CORPORATION
City/State/Country
ASHIGARAKAMI-GUN Kanagawa, JP
Establishment Address
798 MIYANODAI KAISEI-MACHI, ASHIGARAKAMI-GUN Kanagawa 258-8538, JP
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,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
N
Expiration Date (Year)
2026
510(k) Number
K070920
PMA Number
N/A

All Registered Proprietary Names

Synapse 3D Base Tools V7 Synapse Lung Nodule AI FCR 1 Shot Phantom Plus FDX Console (DR-ID300CL) Synapse 3D Brain Perfusion FDR D-EVO with X-ray Detection Feature FDR SE Lite (DR-ID330) FDR Go iQ Mobile X-ray System DR-ID 1200SDK System DryPix Lite (DRYPIX2000) FUJIFILM Tomosynthesis Option for FDR AcSelerate Stationary X-ray System FDR CROSS (DR-XD 3000) Synapse 3D Perfusion Analysis FUJIFILM DryPix Laser Imager DRYPIX Smart (DRYPIX6000) DRYPIX EDGE (DRYPIX 8000) Synapse 3D Optional Tools Endoscope Simulator Synapse 3D Base Tools V6.6 FCRMS FUJI COMPUTED RADIOGRAPHY Synapse 3D Nodule Analysis Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of DR-ID600) DR-ID1200MC FDR D-EVO GL Flat Panel Detector System (DR-ID 1300) FDR D-EVO GL (DR-ID1305SE) DR-ID1300MP FDR AQRO (DR-XD 1000) Biopsy Positioner FDR-2000BPY ASPIRE Cristalle Digital Breast Tomosynthesis Option AMULET Innovality Digital Breast Tomosynthesis Option 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 TANDACT Trocar Synapse 3D Lung and Abdomen Analysis Lung Analysis Resection Synapse 3D Liver and Kidney Analysis Liver Analysis Kidney Analysis FCR CARBON XL-2 (CR-IR359) FCR XL-2 (CR-IR359) Fuji IP Cassette Type CC FCR Prima T2 (CR-IR392) FCR PRIMA Tm(CR-IR392) FCR CARBON (CR-IR357) FCR Prima T2(CR-IR392) FCR XC-2 (CR-IR357) FCR Prima T(CR-IR392) Synapse 3D Base Tools (V7.2) Aspire Cristalle FDR MS-3500 Synapse 3D Colon Analysis Synapse 3D Cardiac Tools Fuji IP Cassette Type PC Fuji IP Cassette Type CH Fuji IP Cassette Type LC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
OEB Lung Computed Tomography System, Computer-Aided Detection Radiology Class 2 892.2050 2026-05-29
LHO Instrument, Quality-Assurance, Radiologic Radiology Class 1 892.1940 2006-10-25
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-06-11
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2024-06-11
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2012-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2012-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2019-11-13
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2025-12-18
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2020-04-10
LMC Camera, Multi Format, Radiological Radiology Class 2 892.2040 2008-03-11
IZF System, X-Ray, Tomographic Radiology Class 2 892.1740 2013-01-30
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
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-01-12
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2018-01-12
LMC Camera, Multi Format, Radiological Radiology Class 2 892.2040 2006-10-05
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-11-26
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 2006-10-25
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2012-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2017-07-06
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2015-11-16
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2017-05-03
IZH System, X-Ray, Mammographic Radiology Class 2 892.1710 2019-07-04
OTE Digital Breast Tomosynthesis Unknown Class 3 N/A 2017-01-17
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2014-11-13
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-09-22
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-04-06
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-04-06
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2008-03-11
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
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2014-03-28
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-01-31
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-08-27
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2013-01-30

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
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23
K961871 Siemens Medical Solutions USA, Inc. FLOUROSPOT T.O.P. 1996-07-31
K122260 Aycan Digitalsysteme GmbH AYCAN MOBILE 2012-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001722928. Last updated year: 2026. Please use registration number 3001722928 when referencing this establishment in official correspondence.
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