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510(k) Data Aggregation

    K Number
    K201094
    Device Name
    iMap 3D Mapping & Navigation System (iMap System)
    Manufacturer
    Date Cleared
    2021-08-16

    (479 days)

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

    CardioNXT, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CardioNXT iMap™ 3D Mapping & Navigation System is intended for the display of compatible electrophysiology catheter position and cardiac electrical activity when used with the MultiLink CS Catheter during conventional electrophysiological procedures. The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.
    Device Description
    The CardioNXT iMap™ 3D Mapping and Navigation System (iMap™ System) is a catheter navigation and mapping system, capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as electroanatomical maps of the cardiac chamber. The contoured surfaces of these threedimensional maps are based on the anatomy of the patient's cardiac chamber. The iMap™ System utilizes electromagnetic tracking and impedance tracking to track conventional catheters and paint the surfaces of cardiac chambers in 3D to generate a patient-specific image of the heart, also called a geometry. The iMap System measures cardiac electrogram (EGM) information from navigated catheter electrodes throughout the heart and displays this information on the patient-specific geometry. The iMap System utilizes a Coronary Sinus(CS)catheter with both electromagnetic sensors and electrodes as a reference for its navigation coordinate system.
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