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510(k) Data Aggregation

    K Number
    K161382
    Device Name
    LVivo Software Application
    Manufacturer
    DIACARDIO, LTD.
    Date Cleared
    2016-07-28

    (71 days)

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

    DIACARDIO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DiaCardio's LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.
    Device Description
    The LVivo System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH) views, to provide fully automated analyses of LV function from the echo examination movies. It also has the ability to measure strain
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