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510(k) Data Aggregation

    K Number
    K982004
    Device Name
    CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS
    Manufacturer
    GENERAL ELECTRIC CO.
    Date Cleared
    1998-08-18

    (71 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K913770,K970980
    Why did this record match?
    Device Name :

    CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CT Coronary Artery Calcification Scoring Option for Advantage Windows is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis. It runs on Advantage Windows independent workstations (K913770).

    Device Description

    A software productivity package that semi-automatically quantified cardiac calcifications by a weighted number instead of manually calculating area of Regions of Interest (ROIs) and the density within each ROI.

    AI/ML Overview

    The provided text is a K982004 510(k) summary for the GE Medical Systems' CT Coronary Artery Calcification Scoring Option for Advantage Windows. It outlines the device's purpose and its substantial equivalence to a predicate device but does not contain information about specific acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and basic device description rather than performance metrics or a detailed study report.

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