BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    GI Genius

    K Number: K211951 · Decision Jul 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    14
    Applicant Total
    4
    Review Days
    30

    Basic Information

    Device Name
    GI Genius
    K Number
    K211951
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cosmo Artificial Intelligence - AI Ltd
    Date Received
    June 23, 2021
    Decision Date
    July 23, 2021
    Product Code
    QNP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QNP Gastrointesinal Lesion Software Detection System

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