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510(k) Data Aggregation

    K Number
    K152160
    Device Name
    Navik 3D
    Manufacturer
    Date Cleared
    2016-02-23

    (204 days)

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

    APN Health, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Navik 3D is intended for catheter-based atrial and ventricular mapping using compatible catheters, and acquired data from compatible fluoroscopy systems and patient recording and monitoring systems. Navik 3D is intended to provide 3D location of these catheters from acquired 2D fluoroscopic images. The device allows real-time display of cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps and cardiac voltage maps.
    Device Description
    Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed. Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care.
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