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    K Number
    K253535

    Validate with FDA (Live)

    Device Name
    Ligence Heart
    Manufacturer
    Ligence Uab
    Date Cleared
    2026-02-27

    (106 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    18 - 150
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Ligence Heart is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or sonographers for clinical decision making. Ligence Heart is indicated for use in adult patients. Ligence Heart has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g., tumors, thrombi).

    Device Description

    Not Found

    AI/ML Overview

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