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510(k) Data Aggregation

    K Number
    K251463
    Manufacturer
    Date Cleared
    2025-09-04

    (115 days)

    Product Code
    Regulation Number
    870.1425
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EnSite X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

    The EnSite X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures.

    Device Description

    The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

    The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

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