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510(k) Data Aggregation
K Number
K100849Device Name
SYNC-RX SYSTEM, MODEL AS00010
Manufacturer
SYNC-RX LTD
Date Cleared
2010-05-21
(56 days)
Product Code
IZI
Regulation Number
892.1600Why did this record match?
Applicant Name (Manufacturer) :
SYNC-RX LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sync-Rx System is an image acquisition and processing system. It is indicated for use as follows:
- To provide quantitative information regarding the calculated dimensions of arterial segments.
- To enhance visualization of the stent deployment region.
- To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.
Device Description
The Sync-Rx System is an image acquisition and processing workstation situated in the coronary catheterization lab and intended to be used during coronary catheterizations. The Sync-Rx System captures the fluoroscopic image stream and performs the following for assisting the interventional cardiologist: Lesion Evaluation: The system performs angiogram selection and quantitative coronary measurements (lesion diameter, vessel diameter, lesion length, percent stenosis). Device positioning, deployment and post-deployment: An on-line enhanced image stream is displayed side-by-side to the existing fluoroscopic image stream. All functions performed by the Sync-Rx System are presented, both in the procedure room and in the control room, on a display that is situated side by side to the already-existing display of the native fluoroscopic image stream.
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