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510(k) Data Aggregation

    K Number
    DEN200055
    Device Name
    GI Genius
    Manufacturer
    Cosmo Artificial Intelligence - AI, LTD
    Date Cleared
    2021-04-09

    (213 days)

    Product Code
    QNP, ONP
    Regulation Number
    876.1520
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cosmo Artificial Intelligence - AI, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.
    Device Description
    The GI GENIUS™ is an artificial intelligence/machine learning (AI/ML) device system comprised of software, hardware, and accessories that is intended for polyp detection during standard white-light colonoscopy. The device system generates a video on the main endoscopy display that contains the original live video together with superimposed markers (in the form of green boxes) that appear when a lesion is detected. The GI Genius takes the Serial Digital Interface (SDI) output stream from the video endoscope processor as an input and then generates an SDI output stream to the existing monitor/display system containing the original video stream with additional markers superimposed on it. In essence, the system is inserted into the video stream just prior to it being displayed to the user/operator.
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