BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SmartCeph

    Reg #: 3009149931 · FEI: 3009149931 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORTHO2
    Registration Number
    3009149931
    FEI Number
    3009149931
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1107 Buckeye Ave
    City
    Ames
    State
    IA
    ZIP
    50010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190162

    Owner / Operator

    Firm Name
    Ortho2
    Operator Number
    10061548
    Address
    1107 Buckeye Ave
    City
    Ames
    State
    IA
    Postal Code
    50010
    Country
    US
    Correspondent
    Darcy Dakovich

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    SmartCeph Premier Imaging

    Establishment Types

    Manufacture Medical Device