BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    GE Optima 660 CT

    Reg #: 3010789868 · FEI: 3010789868 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CIS COMPUTERISED IMAGING SERVICES PTY LTD
    Registration Number
    3010789868
    FEI Number
    3010789868
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Waverley Street, Suite 406, Level 4
    City
    Bondi Junction New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K110227

    Owner / Operator

    Firm Name
    CIS Computerised Imaging Services Pty Ltd
    Operator Number
    10047067
    Address
    3 Waverley Street, Suite 406, Level 4
    City
    Bondi Junction
    State
    New South Wales
    Postal Code
    2022
    Country
    AU

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

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

    Proprietary Names

    GE Optima 660 CT

    Establishment Types

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