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510(k) Data Aggregation

    K Number
    K230209
    Device Name
    Sonix Health
    Manufacturer
    Ontact Health Co., Ltd.
    Date Cleared
    2023-10-20

    (268 days)

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

    Ontact Health Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sonix Health is intended for quantifying and reporting echocardiography for use by or on the order of a licensed physician. Sonix Health accepts DICOM-compliant medical images acquired from ultrasound imaging devices. Sonix Health is indicated for use in adult populations.
    Device Description
    Sonix Health comes with the following functions: - Checking ultrasound multiframe DICOM - Echocardiography multiframe DICOM classification and automatic measurement. - Verification of the results and making adjustments manually. - Providing the report for analysis Sonix Health will be offered as SW only, to be installed directly on customer PC hardware. Sonix Health is DICOM compliant and is used within a local network. Sonix Health utilizes a two-step algorithm. A single identification model identifies a view in the first step. The second step performs the deep learning according to the view. The deep learning algorithms for the second step are categorized as B-mode, and Doppler algorithms. The main algorithm of Sonix Health is to identify the view and segment the anatomy in the image.
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