BEUDAMED
    FDA Registration Active 🇫🇷 France

    GE Brightspeed Elite 16 Slice CT

    Reg #: 3023003446 · FEI: 3023003446 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BLOCK IMAGING SAS
    Registration Number
    3023003446
    FEI Number
    3023003446
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 rue des Vosges
    City
    Weyersheim Bas-Rhin
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K082816

    Owner / Operator

    Firm Name
    Block Imaging SAS
    Operator Number
    10086857
    Address
    1845 Cedar Street
    City
    Holt
    State
    MI
    Postal Code
    48842
    Country
    US
    Correspondent
    Grace Lyon

    US Agent

    Business Name
    BLOCK IMAGING INTERNATIONAL
    Contact Name
    Micah Plimpton
    Address
    1845 Cedar Street
    City
    Holt
    State
    MI
    ZIP
    48842
    Country
    US
    Email
    [email protected]
    Phone
    517 6688800

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    GE Brightspeed Elite 16 Slice CT GE BrightSpeed Edge Select GE BrightSpeed Excel Select GE Optima CT540 GE BrightSpeed Elite Select GE BrightSpeed Elite

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device