BEUDAMED
    FDA Registration Active 🇨🇳 China

    FUJIFILM Imaging System (Suzhou) Co., Ltd.

    Reg #: 3008787461 · FEI: 3008787461 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FUJIFILM Imaging System (Suzhou) Co., Ltd.
    Registration Number
    3008787461
    FEI Number
    3008787461
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    138 Chang Jiang Road, New District
    City
    Suzhou Jiangsu
    Country
    CN

    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 Ave Ste 100
    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
    Camera, Multi Format, Radiological LMC
    Full Field Digital, System, X-Ray, Mammographic MUE

    Proprietary Names

    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) DryPix Lite (DRYPIX2000) FCR PRIMA Tm (CR-IR392) Aspire CRm (CR-IR359) FUJIFILM DryPix Laser Imager DRYPIX Smart (DRYPIX6000) DRYPIX EDGE (DRYPIX 8000)

    Establishment Types

    Manufacture Medical Device