Device Dossier

X-ray system, diagnostic, fluoroscopic, angiographic, application program software

Device Dossier for X-ray system, diagnostic, fluoroscopic, angiographic, application program software (X-ray system, diagnostic, fluoroscopic,…

Intended purpose

Intended to assist the physician during percutaneous coronary interventions in correlating the device position to the coronary vasculature, by providing a motion compensated overlay of this coronary vasculature. The FFR/iFR Roadmap feature is intended to assist the physician during percutaneous coronary interventions in relating the intravascular blood pressure measurement to its anatomical location. FFR/iFR roadmap visualizes the position of the pressure wire and the coronary artery on an X-ray image at the moment that an intravascular blood pressure measurement was performed as well as the intravascular blood pressure measurement values themselves. Suitable for use with the entire adult human population.

TGA Public Summary