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510(k) Data Aggregation

    K Number
    K120301
    Device Name
    MEDIGUIDE TECHNOLOGY
    Manufacturer
    ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS
    Date Cleared
    2012-02-24

    (24 days)

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

    ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MediGuide Technology System is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide enabled (equipped with a MediGuide sensor) diagnostic or therapeutic invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.
    Device Description
    The MediGuide Technology System, used in conjunction with an X-ray System, employs magnetic positioning technology to track a MediGuide enabled diagnostic or therapeutic invasive device for the 3D position relative to any X-Ray image, in real-time or previously recorded cine-loop. The MediGuide Technology System includes two optional software packages. The Coronary package includes the Coronary application, and it supports coronary procedures. The Cardiac package includes the Cardiac Navigation and the Cardiac Navigation with Angio Survey™ application, both support cardiac procedures. The most fundamental capability of the MediGuide Technology is the positioning and navigation of MediGuide enabled devices. This feature enables projection of the real time position of a MediGuide sensor (and thus of the MediGuide enabled device) on real time 2D X-Ray images (live mode) or in a recorded mode (the MediGuide enabled device tip real time position is superimposed on a previously recorded cine loop or still image). The MediGuide Technology enables simultaneous tracking of up to three MediGuide enabled devices.
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