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510(k) Data Aggregation

    K Number
    K102905
    Device Name
    GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)
    Manufacturer
    MEDIGUIDE, LTD.
    Date Cleared
    2010-10-29

    (29 days)

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

    MEDIGUIDE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K091780
    Device Name
    GUIDED MEASUREMENT CATHETER (GMC)
    Manufacturer
    MEDIGUIDE, LTD.
    Date Cleared
    2009-10-16

    (121 days)

    Product Code
    DQO, DOO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIGUIDE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GMC™ device is a gMPS™ enabled intravascular catheter intended for the diagnostic evaluation of the coronary vasculature in patients who are candidates for coronary angiography and/or Percutaneous Coronary Intervention (PCI). The GMC™ is used with compatible gMPS™ system to enable real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication, and landmarking. The System is indicated for use as an adjunct to fluoroscopy.
    Device Description
    The Guided Measurement Catheter (GMC™) is a Medical Positioning System (gMPS™) enabled coronary diagnostic catheter designed to allow catheter tracking during a routine diagnostic catheterization of the coronary arteries using the MediGuide's gMPS™ system. The catheter includes an embedded gMPS™ sensor in order to allow its tracking by the gMPSTM system. The GMC™ gMPS™ enabled catheter is intended to be used during a percutancous coronary procedure, and similarly to an IVUS assessment, inserted to a target coronary artery, usually past a stenotic region, and then pulled back manually, to screen the selected arterial segment. As the pullback is completed, the 3D trace of the catheter's trajectory is reconstructed and displayed separately in a 3D display, and also superimposed on the 2D X-ray image by the gMPS™ system. The superimposed trace, the Smart Trace, is color coded to show an indication of the angular percent of foreshortening of the artery as it exists in the respective X-ray image. A model of the artery's lumen is automatically generated by the gMPS™ system from only one X-ray image, taken from a single angle (projection).
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    K Number
    K091781
    Device Name
    GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
    Manufacturer
    MEDIGUIDE, LTD.
    Date Cleared
    2009-10-16

    (121 days)

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

    MEDIGUIDE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guided Medical Positioning System (gMPS™) is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a gMPS™ enabled (equipped with a gMPS™ 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 gMPS™, used in conjunction with an X-ray System, employs magnetic positioning technology to track a gMPS™ 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 gMPS™ system is intended to provide the following: Catheter tip positioning and navigation - The real time position of the gMPSTM sensor (and thus of the gMPS™ enabled device) is displayed in real time ("Live") fluoroscopy mode or in a recorded mode. Smart trace (foreshortening indication) - A 3D trace of the gMPS™ enabled device trajectory is projected and superimposed on the 2D X-ray images (either on live fluoroscopy, recorded cine-loop or recorded still image). 3D reconstructed model - The system reconstructs a 3D model of the inspected anatomical structure. Quantitative longitudinal measurements - The measurements are based on the 3D trace, thus overcoming length measurement errors induced by the foreshortening effect. Quantitative Coronary Angiography (OCA) - While working in conjunction with gMPSTM enabled coronary device, the gMPS™ provides 3D QCA. Virtual landmarking - A manually marked point or region of interest superimposed on X-ray images (real-time angiography and cine-loop) and on the 3D reconstruction.
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