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CATHWORKS LTD

FFRANGIO · Gastroenterology and Urology

510(k): 2 Recall: 0 UDI: 2 MAUDE: 0 Class.: 0

510(k) Clearances (2)

FFRangio

2019-12-09

Substantially Equivalent

FFRangio System

2018-12-19

Substantially Equivalent

UDI Registrations (2)

FFRangio

The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-‎based software ‎device that provides physicians with a quantitative analysis of ‎functional significance of a coronary ‎lesion, similar to invasive FFR (Fractional Flow ‎Reserve), and a qualitative three-dimensional model of ‎the demonstrated coronary ‎arteries, during routine PCI procedure. The FFRangio™ System perform…

FFRangio

The FFRangio System is a non invasive image based software device