BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cerner SkyVue with Mammography

    Reg #: 3013546957 · FEI: 3013546957 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Cerner Corporation
    Registration Number
    3013546957
    FEI Number
    3013546957
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8779 Hillcrest Rd
    City
    Kansas City
    State
    MO
    ZIP
    64138
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070394

    Owner / Operator

    Firm Name
    Cerner Corporation
    Operator Number
    9011113
    Address
    8779 Hillcrest Road, --
    City
    Kansas City
    State
    MO
    Postal Code
    64138
    Country
    US
    Correspondent
    Jeff Mauzey

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Cerner SkyVue with Mammography

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device