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510(k) Data Aggregation

    K Number
    K244023
    Device Name
    MAGENTIQ-COLO (ME-APDS)
    Manufacturer
    Magentiq Eye LTD
    Date Cleared
    2025-01-24

    (28 days)

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

    Magentiq Eye LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ME-APDS (Magentig Eye's Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist the endoscopist in identifying lesions during colonoscopy procedure by highlighting reqions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice. ME-APDS is trained to process video images which may contain regions consistent with polyps. ME-APDS is limited for use with standard white-light endoscopy imaging only. ME-APDS is intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.
    Device Description
    ME-APDS™MAGENTIQ-COLO is intended to be used as an adjunct to the common video colonoscopy procedure. The system application aims to assist the endoscopist in identifying lesions, such as polyps, during the colonoscopy procedures in real time. The device is not intended to be used for diagnosis or characterization of lesions, and does not replace clinical decision making. The system acquires the digital video output signal from the local endoscopy camera and processes the video frames. It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different types of mucosal abnormalities such as polyps. The output video with the detected lesions is presented on a separate screen, highlighting the suspicious areas on the original video. The user can also take snapshots of the videos, with and without the highlighting of the suspicious areas, record videos and view in full screen mode.
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    K Number
    K223473
    Device Name
    ME-APDS™; MAGENTIQ-COLO™
    Manufacturer
    Magentiq Eye LTD
    Date Cleared
    2023-07-25

    (250 days)

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

    Magentiq Eye LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ME-APDS (Magentig Eye's Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist in identifying lesions during colonoscopy procedure by highlighting regions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice. The ME-APDS is trained to process video images which may contain regions consistent with polyps. The ME-APDS is limited for use with standard white-light endoscopy imaging only. The ME-APDS is intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.
    Device Description
    The ME-APDS (Magentig Eve's Automatic Polvo Detection System) is intended to be used as an adjunct to the common video colonoscopy procedure. The system application aims to assist the endoscopist in identifying lesions, such as polyps, during the colonoscopy procedures in real time. The device is not intended to be used for diagnosis or characterization of lesions, and does not replace clinical decision making. The system acquires the digital video output signal from the local endoscopy camera and processes the video frames. It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different tvpes of mucosal abnormalities such as polyps. The output video with the detected lesions is presented on a separate touchscreen, supplied as part of the ME-APDS, highlighting the suspicious areas on the original video. The output of the system can also be presented on additional monitors in the procedure room using the 1x4 HDMI Splitter supplied with the system. The user can also take snapshots of the videos, with and without the highlighting of the suspicious areas, record videos and view in full screen mode.
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