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510(k) Data Aggregation

    K Number
    K970970
    Device Name
    CARDIOMATCH
    Manufacturer
    Date Cleared
    1997-06-13

    (88 days)

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

    FOCUS MEDICAL SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cardiac Stress and Rest SPECT Imaging Processing Software is a diagnostic software program that quantitatively analyzes myocardial perfusion in patients injected with Cardiolite® (Tc Sestamibi) or Thallium following a rest/stress Single Photon Emission Computerized Tomography (SPECT) acquisition protocol.
    Device Description
    The program automatically determines the alignment parameters for the stress and rest reconstructed MPS SPECT images and, following operator venification of these parameters, performs a size and shape normalization to a template using a published and independently validated 3D image registration method. The normalized images are then compared to a normal distribution and the results of this comparison are used to generate a visual and quantitative representation of the extent and location of perfusion defects. Results are presented in the form of 3D representation of the normalized images including a visualization of the abnormalities as well as a table indicating the number. extent and location of abnormalities.
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