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510(k) Data Aggregation

    K Number
    K110071
    Device Name
    COR ANALYZER
    Manufacturer
    RCADIA MEDICAL IMAGING LTD.
    Date Cleared
    2011-01-31

    (21 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K072242
    Predicate For
    K123646
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The COR Analyzer is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology. COR Analyzer has abilities for coronary vessels segmentations, abnormalities display and processing.

    Device Description

    The COR Analyzer (unmodified) device is a post processing software application which runs on a standalone server, work-station. The device input is Computed Tomography (CTA) set of images. The Device Software provides the location and segmentation of the (RCA, LM, LAD & LCX) coronary arteries. The software also labels these arteries and displays them uniquely colored in a 3D view. Artery changes of volumes are processed and deviations from expected values are detected. When a deviation exceeds threshold value it is displayed on the 3D view. The device has been modified to include also the location, segmentation & processing of major branches (of the RCA, LM, LAD & LCX) arteries. The device reliability & user interface have been modified to improve convenience of use.

    AI/ML Overview

    The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. It states that "Its performance has been validated by comparison the processing results to experienced radiologists' interpretation of the same data and to the processing results of the predicate device." However, it does not elaborate on the specifics of this validation study.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 based on the given information. The document is a 510(k) summary, which typically provides a high-level overview. Detailed study results and acceptance criteria are usually found in the full 510(k) submission, which is not provided here.

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