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510(k) Data Aggregation

    K Number
    K212493
    Device Name
    KODEX – EPD™ System 1.5.0
    Manufacturer
    Philips Medical Systems Nederland, B.V. (PMSN)
    Date Cleared
    2022-10-24

    (441 days)

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

    Philips Medical Systems Nederland, B.V. (PMSN)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODEX-EPD™ System 1.5.0 is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD ™ System 1.5.0 provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.
    Device Description
    The KODEX-EPD™ System 1.5.0 is a catheter-based cardiac mapping system designed to acquire and analyze individual data points, and use this information to display 3D electro-anatomical maps of the human heart in real-time. The information needed to create the cardiac maps is acquired using standard electrophysiological (EP) catheters and proprietary external sensors. KODEX - EPD™ continuously collects electromagnetic signals from all sensors and electrodes attached to it. The system then uses these to create a 3D image of the chamber, and superimposes the real time catheter position on the chamber image. In addition, the KODEX – EPD™ System 1.5.0 supports representation of the electrical activity of cardiac chambers, based on the intra cardiac signals received from the all catheters and body surface signals.
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