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 for imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. 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