BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Koios DS

    Reg #: 3010119782 · FEI: 3010119782 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Koios Medical, Inc.
    Registration Number
    3010119782
    FEI Number
    3010119782
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    242 West 38th Street, 14th Floor
    City
    New York
    State
    NY
    ZIP
    10018
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212616

    Owner / Operator

    Firm Name
    Koios Medical, Inc.
    Operator Number
    10054621
    Address
    242 West 38th Street, 14th Floor
    City
    New York
    State
    NY
    Postal Code
    10018
    Country
    US
    Correspondent
    Graham Anderson

    Products

    Device Name Product Code
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Koios DS

    Establishment Types

    Manufacture Medical Device