BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FCR XC-2 (CR-IR357)

    Reg #: 2155 · FEI: 2155 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office
    Registration Number
    2155
    FEI Number
    2155
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1250 TAKEMATSU
    City
    MINAMIASHIGARA-SHI Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K042023

    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

    FCR XC-2 (CR-IR357) FCR Prima T2 (CR-IR392) FCR CARBON XL-2 (CR-IR359) FCR Prima T(CR-IR392) FCR Prima T2(CR-IR392) FCR XL-2 (CR-IR359) FCR PRIMA Tm(CR-IR392) Fuji IP Cassette Type CC FCR CARBON (CR-IR357)

    Establishment Types

    Manufacture Medical Device