BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Koios DS

    K Number: K242130 · Decision Nov 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    21
    Applicant Total
    3
    Review Days
    116

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    Basic Information

    Device Name
    Koios DS
    K Number
    K242130
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2060
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Koios Medical, Inc.
    Date Received
    July 22, 2024
    Decision Date
    November 15, 2024
    Product Code
    POK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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    Other Clearances by Koios Medical, Inc.

    K Number Device Name
    K212616 Koios DS
    K190442 Koios DS for Breast