BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJIFILM CORPORATION

    Reg #: 3001722928 · FEI: 3001722928 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    94
    Establishment Types
    3
    Classifications
    19

    Registration Details

    Registration Name
    FUJIFILM CORPORATION
    Registration Number
    3001722928
    FEI Number
    3001722928
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    798 MIYANODAI KAISEI-MACHI
    City
    ASHIGARAKAMI-GUN Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K243762
    PMA Number
    P050014

    Owner / Operator

    Firm Name
    FUJIFILM CORPORATION
    Operator Number
    8031568
    Address
    26-30, Nishiazabu 2-chome
    City
    MINATO-KU
    State
    Tokyo
    Postal Code
    106-8620
    Country
    JP

    US Agent

    Business Name
    FUJIFILM Healthcare Americas Corporation
    Contact Name
    Randy Vader
    Address
    81 Hartwell Ave Ste 100
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US
    Email
    [email protected]
    Phone
    360 3566821

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    Lung Computed Tomography System, Computer-Aided Detection OEB
    Instrument, Quality-Assurance, Radiologic LHO
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Mobile IZL
    Camera, Multi Format, Radiological LMC
    System, X-Ray, Tomographic IZF
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Tomography, Computed JAK
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, X-Ray, Mammographic IZH
    Digital Breast Tomosynthesis OTE
    Laparoscope, General & Plastic Surgery GCJ
    Accelerator, Linear, Medical IYE
    Film, Radiographic IWZ
    System, X-Ray, Stationary KPR
    Screen, Intensifying, Radiographic EAM

    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 FCR PRIMA Tm (CR-IR392) Aspire CRm (CR-IR359) ASPIRE Cristalle Synapse 3D Tensor Analysis FDR D-EVO Mobile Compo (DR-ID800) Aspire Cristalle (DVIIm) Synapse 3D Blood Flow Analysis FUJIFILM FDR Dual Energy Subtraction Option (DES) 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) FUJI IMAGING PLATE ST-VI

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility