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510(k) Data Aggregation

    K Number
    K220039
    Device Name
    AutoSeg
    Manufacturer
    AI Medic Inc.
    Date Cleared
    2022-07-20

    (196 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    AI Medic Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AutoSeg-H is medical imaging software that is intended to professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography). AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including: - Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries. - Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves. - 4-Chamber Analysis: which is intended for automatic extraction of the left atrium, and right ventricle from CT.
    Device Description
    AutoSeg-H(V1.0.0.01) is software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. AutoSeg-H(V1.0.0.01) runs on Windows standalone installed on a commercial general-purpose Windows-compatible computer and accepts DICOM compliant medical images acquired from a CT. The AutoSeg-H is not connected to a PACS system directly but retrieves saved image data from a computer. Image data obtained from the computer are used for display, image processing, analysis, etc. AutoSeg-H cannot be used to interpret Mammography images. The main functions of AutoSeg-H are shown below. - Coronary Artery Analysis (CT) - - Aortic Valve Analysis (CT) - - -4-Chamber Analysis (CT)
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