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510(k) Data Aggregation

    K Number
    K162440
    Device Name
    CardioInsight Cardiac Mapping System
    Manufacturer
    CARDIOINSIGHT TECHNOLOGIES, INC
    Date Cleared
    2016-11-04

    (65 days)

    Product Code
    DQK
    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 Medtronic CardioInsight® Cardiac Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
    Device Description
    The Medtronic CardioInsight® Cardiac Mapping System is a non-invasive mapping system for beat-by-beat, multichamber, 3D mapping of the heart. The CardioInsight Cardiac Mapping 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 ECG signals in concert with the CT scan information (geometrical information) are used in mathematical algorithms to transform the measured body surface signals into epicardial signals via solving the cardiac inverse problem. The CardioInsight Cardiac Mapping System software uses this data to provide various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The CardioInsight Cardiac Mapping System system is mobile and can be used for mapping at the patient's bedside or in the EP lab.
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    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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    K Number
    K140497
    Device Name
    ECVUE MAPPING SYSTEM
    Manufacturer
    CARDIOINSIGHT TECHNOLOGIES, INC
    Date Cleared
    2014-11-19

    (265 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, 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.
    Ask a Question

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