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510(k) Data Aggregation

    K Number
    K211326
    Device Name
    EndoScreener
    Date Cleared
    2021-11-19

    (203 days)

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

    Chengdu Wision Medical Device Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EndoScreener is intended as a stand-alone software for real-time automatic detection of polyps in colonoscopy video stream during the procedure. Physicians are responsible for reviewing the identified areas of suspect polyps presented by EndoScreener and confirming the presence or absence of a polyp on the evaluation of the colonoscopy image on their own medical judgment. EndoScreener is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make or confirm a diagnosis. EndoScreener is indicated for use by licensed endoscopists who perform colonoscopy in adults. EndoScreener is indicated for use with white light colonoscopy.
    Device Description
    The EndoScreener is a computer-assisted detection device for colorectal polyps. EndoScreener takes as input colonoscopy video stream from an endoscopy device, which is analyzed in real-time. The device output consists of blue boxes overlaid onto the colonoscopy images to highlight regions of potential polyp. EndoScreener also has the option to sound an alert to the physicians who perform the colonoscopy when a polyp has been detected. Following detection by EndoScreener, the physician must confirm the EndoScreener findings based on his/her own medical judgment.
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