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510(k) Data Aggregation

    K Number
    K192372
    Device Name
    ASCEND Image Viewer
    Manufacturer
    Date Cleared
    2020-02-14

    (168 days)

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

    Ascend Hit

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ASCEND Image Viewer is a software-only medical device intended for use by trained clinicians to display medical images. ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types. ASCEND Image Viewer is for prescription use only.
    Device Description
    The ASCEND Image Viewer is a Medical Device for viewing and measuring cardiovascular echocardiograms in DICOM format. The software has features for displaying and measuring cardiovascular images acquired from echocardiograms. Images supported include: - . 2D - Color Doppler - M-mode - . Spectral Doppler (Pulsed Wave and Continuous Wave) The ASCEND Image Viewer provides Cine play review and control. Standard Review supported study types include: - TTE - TEE - Cath - . Stress Echo - Vascular Supported Measurements include: - Linear - . Volume (method of discs) - Velocity time integral - Pressure half-time - . Area - Time - Velocity - Angle (measurement of two lines with a common vertex drawn on the image) . The user can make measurements which persist for later use within the ASCEND Image Viewer.
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