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510(k) Data Aggregation

    K Number
    K251792

    Validate with FDA (Live)

    Device Name
    GenesisX RMN® (Robotic Magnetic Navigation) System with Navigant®™ Workstation (NWS) and Cardiodrive® (001-014000-1)
    Manufacturer
    Stereotaxis, Inc.
    Date Cleared
    2025-11-06

    (148 days)

    Product Code
    DXX
    Regulation Number
    870.1290
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K193147,K021555
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GenesisX RMN is intended to navigate compatible magnetic devices in the chambers of the heart and arterial and venous vasculature by orienting the device tip in a desired direction.

    Device Description

    Stereotaxis GenesisX RMN with Navigant™ Workstation (NWS) and Cardiodrive® System (GenesisX) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) using computer-controlled permanent magnets to orient or steer the tip of a magnetic device, and remotely advance and retract only compatible magnetic electrophysiology (EP) catheters inside the patient's heart. GenesisX incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

    AI/ML Overview

    N/A

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