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510(k) Data Aggregation

    K Number
    K032500
    Device Name
    MODIFICARION TO WACKERS-LIU CQ SOFTWARE
    Date Cleared
    2003-08-25

    (12 days)

    Product Code
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECLIPSE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The revised Wackers-Liu CQ® Software is a stand-alone software package for quantification of emission computed tomography (ECT) myocardial perfusion images. The data generated by the Wackers-Liu CQ® Software is intended to be used by the physician in addition to other complementary data in the evaluation of cardiac function and blood supply. It is not meant to replace or eliminate the physician's standard visual interpretation of the patient study or the integration of additional clinical and/or diagnostic information (patient history, stress and/or rest EKG, echocardiogram, etc.) prior to making any final clinical diagnostic or treatment decision. The Wackers-Liu CQ® Software also provides for transmission of ECT images over the internet.
    Device Description
    The revised Wackers-Liu CQ® Software is a stand-alone software package. This original product is the automated commercial version of a totally integrated and manually operated cardiac imaging analysis package developed by Drs. Wackers and Liu, and others at the Yale University Cardiovascular Nuclear Imaging Laboratory and described extensively in the peer-reviewed literature. Modifications to the cleared Wackers-Liu CQ® Software consist of changes to the handling of non-circular left ventricular edges and counting voxels. Changes to the Wackers-Liu CQ® Software are transparent to the user.
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    K Number
    K002229
    Device Name
    WACKERS-LIU CQ SOFTWARE
    Date Cleared
    2000-10-20

    (88 days)

    Product Code
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECLIPSE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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