BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FUJIFILM Healthcare Americas Corporation

    Reg #: 1528028 · FEI: 1528028 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FUJIFILM Healthcare Americas Corporation
    Registration Number
    1528028
    FEI Number
    1528028
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1959 Summit Commerce Park
    City
    Twinsburg
    State
    OH
    ZIP
    44087
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163505

    Owner / Operator

    Firm Name
    FUJIFILM Healthcare Americas Corporation
    Operator Number
    10082284
    Address
    81 Hartwell Avenue, Suite 100
    City
    Lexington
    State
    MA
    Postal Code
    02421
    Country
    US
    Correspondent
    Randy Vader

    Products

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

    Proprietary Names

    C9150LA S12BP4 Neurosurgery Probe UST-9150

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility