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