Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K201250
    Device Name
    SQuEEZ Software
    Manufacturer
    Date Cleared
    2020-12-18

    (221 days)

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

    Cardiowise, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SQuEEZ Software is an image analysis software application for cardiac Computer Tomography (CT) studies to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The software calculates a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code the wall motions of the heart. Tools are provided to display regional motion properties of the heart.
    Device Description
    Cardiowise SQuEEZ Software is a post processing image analysis software application for cardiac Computer Tomography (CT) studies to assist cardiologists and radiologists in assessing left ventricle function when producing a cardiac evaluation. SQuEEZ Software enables a quantitative evaluation of the regional myocardial strain using the data from an ultra-high-resolution cardiac CT scan that requires an acquisition time of as short as a single heartbeat. This is done by calculating a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code the wall motions of the heart. The resulting analysis is graphically presented in threedimensional color contour maps or regional graphical representations that indicate the level of strain the left ventricle experiences during the cardiac cycle.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1