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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    RCADIA MEDICAL IMAGING LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K072242
    Device Name
    COR ANALYZER II, MODEL V1.7
    Manufacturer
    RCADIA MEDICAL IMAGING LTD.
    Date Cleared
    2007-09-11

    (29 days)

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

    RCADIA MEDICAL IMAGING LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COR Analyzer II 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 II 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 II has abilities for coronary vessels segmentations, abnormalities display and processing.
    Device Description
    COR Analyzer I is a post processing software application which runs on a stand-alone Windows based work-station. The device input is Computed Tomography Angiography (CTA) set of images. The received data is displayed on the workstation screen, reviewed and selected by the operator for processing. Software provides the location and segmentation of the coronary artery tree. The software also labels the coronary arteries and displays them uniquely colored in a 3D view. The 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.
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    K Number
    K063548
    Device Name
    COR ANALYZER 1, VERSION 1.4
    Manufacturer
    RCADIA MEDICAL IMAGING LTD.
    Date Cleared
    2007-01-22

    (59 days)

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

    RCADIA MEDICAL IMAGING LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COR Analyzer I is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The COR Analyzer I 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 I has abilities for coronary vessels segmentations, abnormalities display and processing.
    Device Description
    COR Analyzer I is a post processing software application which runs on a stand-alone Windows based work-station. The device input is Computed Tomography Angiography (CTA) set of images. The received data is displayed on the workstation screen, reviewed and selected by the operator for processing. The application enables interactive user-software process in which the user chooses a CT slice, points on the selected coronary vessel and the software present the entire selected vessel as a stretched image. In a reversed process, the user can mark a specific point on the stretched vessel and the software retrieves and displays the original correspondent CT slice. COR Analyzer I output results can be stored for future analysis.
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