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510(k) Data Aggregation

    K Number
    K223322
    Device Name
    Argus Cognitive ReVISION Software
    Date Cleared
    2023-07-24

    (266 days)

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

    Argus Cognitive, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for use of the Argus Cognitive ReVISION Software are quantification and reporting of right ventricle (RV) structures and function of patients (adults only) with suspected disease to support physicians' diagnosis.
    Device Description
    The Argus Cognitive ReVISION Software ("ReVISION Software") assesses global and segmental function of the right ventricle (RV) of the heart via the decomposition of longitudinal, radial, and anteroposterior motions of the RV walls and quantifies their relative contribution to global RV ejection fraction along with longitudinal, circumferential and area strains using 3D datasets obtained by echocardiography. Segmentation is performed on the end-diastolic 3D RV model using a rule-based, non-AI/ML algorithm to have 15 RV segments. This segmentation is then projected to all models in the corresponding cardiac cycle.
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