Device Dossier

Ultrasound system, imaging, cardiovascular

Device Dossier for Ultrasound system, imaging, cardiovascular (Ultrasound system, imaging, cardiovascular, Class IIa, sponsor Philips Electronics). ARTG…

Intended purpose

An image acquisition and processing system; used to provide quantitative information regarding the calculated dimensions of arterial segments, enhance visualisation of the stent deployment region, to be used in-procedure in the catheterization lab and offline for post-procedural analysis, to obtain a co-registration of an angiographic x-ray and IVUS images and to obtain a co-registration of an angiographic x-ray and intravascular blood pressure values.

TGA Public Summary