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510(k) Data Aggregation

    K Number
    K150990
    Device Name
    ECVUE Mapping System
    Manufacturer
    CardioInsight Technologies, Inc.
    Date Cleared
    2015-07-02

    (78 days)

    Product Code
    DQK, DOK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    CardioInsight Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CardioInsight ECVUE Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
    Device Description
    ECVUE is a non-invasive mapping system for beat-by-beat, multi-chamber, 3D mapping of the heart. The system displays cardiac maps and virtual electrograms from real-time chest ECG signals (measured by a Sensor Array placed on the torso) and CT scan data. The ECVUE software provides various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The system is mobile and can be used for mapping at the patient's bedside or in the EP lab.
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