BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Prosound 6

    Reg #: 3032109225 · FEI: 3032109225 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office
    Registration Number
    3032109225
    FEI Number
    3032109225
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-1, Shintoyofuta
    City
    Kashiwa-shi Chiba
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K080176

    Owner / Operator

    Firm Name
    FUJIFILM Corporation
    Operator Number
    10081521
    Address
    26-30, Nishiazabu 2-chome
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    106-8620
    Country
    JP
    Correspondent
    Randy Vader

    US Agent

    Business Name
    FUJIFILM Healthcare Americas Corporation
    Contact Name
    Randy Vader
    Address
    81 Hartwell Ave Ste 300
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US
    Email
    [email protected]
    Phone
    360 3566821

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Prosound 6

    Establishment Types

    Manufacture Medical Device