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510(k) Data Aggregation
K Number
K120301Device Name
MEDIGUIDE TECHNOLOGY
Manufacturer
ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS
Date Cleared
2012-02-24
(24 days)
Product Code
DQK, DOK
Regulation Number
870.1425Why 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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