Device Dossier

Ultrasound system, imaging, cardiovascular

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

Intended purpose

An ultrasound imaging system designed exclusively for use in extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the peripheral blood vessels. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic 2- or 3-dimensional images of human anatomy.

TGA Public Summary