BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOFIA

    Reg #: 3006110251 · FEI: 3006110251 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IVU IMAGING CORPORATION
    Registration Number
    3006110251
    FEI Number
    3006110251
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    935 South Kimball Ave. Suite 166
    City
    Southlake
    State
    TX
    ZIP
    76092
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080555

    Owner / Operator

    Firm Name
    iVu Imaging Corporation
    Operator Number
    10026216
    Address
    4121 Grace Lane
    City
    Grapevine
    State
    TX
    Postal Code
    76051
    Country
    US
    Correspondent
    Mark Stribling

    Products

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

    Proprietary Names

    SOFIA

    Establishment Types

    Manufacture Medical Device