BEUDAMED
    FDA Registration Active 🇨🇳 China

    FCR PRIMA Tm (CR-IR392)

    Reg #: 3008787461 · FEI: 3008787461 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FUJIFILM Imaging System (Suzhou) Co., Ltd.
    Registration Number
    3008787461
    FEI Number
    3008787461
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    138 Chang Jiang Road, New District
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K111646

    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
    Full Field Digital, System, X-Ray, Mammographic MUE

    Proprietary Names

    FCR PRIMA Tm (CR-IR392) Aspire CRm (CR-IR359)

    Establishment Types

    Manufacture Medical Device