BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FDR ES II G43

    Reg #: 3001722928 · FEI: 3001722928 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FUJIFILM CORPORATION
    Registration Number
    3001722928
    FEI Number
    3001722928
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    798 MIYANODAI KAISEI-MACHI
    City
    ASHIGARAKAMI-GUN Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K142003

    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 Avenue, Suite 300
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US
    Email
    [email protected]
    Phone
    360 3566821

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    FDR ES II G43 FDR ES II C43 FDR ES C43 (DR-ID1274SE) FDR D-EVO II C35 (DR-ID 1211SE) FDR D-EVO II (DR-ID1200) FDR ES G35 (DR-ID1271SE) FDR ES G43 (DR-ID127SE) FDR ES(DR-ID 1270) FDR D-EVO II C24 (DR-ID 1213SE) FDR ES C35 (DR-ID1273SE) FDR D-EVO II G35 (DR-ID1201SE) FDR D-EVO II Flat Panel Detector System (DR-ID1200) FDR D-EVO II G43 (DR-ID1202SE) FDR D-EVO II C43 (DR-ID 1212SE) FDR ES II G35 FDR ES II (DR-ID 1280) DR-ID 1284SE DR-ID 1281SE DR-ID 1285SE DR-ID 1283SE DR-ID 1280 FDR ES II C25 DR-ID 1282SE FDR ES II C35

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device