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510(k) Data Aggregation

    K Number
    K130779
    Device Name
    LVIVO EF SYSTEM
    Manufacturer
    DIACARDIO, LTD
    Date Cleared
    2013-08-15

    (147 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K072090,K070792
    Why did this record match?
    Device Name :

    LVIVO EF SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DiaCardio's LVivo EF Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.

    Device Description

    The LVivoEF 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.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the LVivo EF Software Application (K130779), based on the provided text:

    Acceptance Criteria and Device Performance

    The provided text only explicitly states one primary endpoint and the corresponding result. The exact acceptance criteria (i.e., the numerical threshold for success) are not explicitly stated, but the device's performance is reported to have met this primary endpoint.

    Acceptance Criteria (Implied)Reported Device Performance
    Strong positive correlation between LVivoEF and Manual Biplane Method (MBP) for biplane Ejection Fraction (EF)Pearson correlation coefficient (r) = 0.88, p
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