Device Dossier

Ultrasound system, imaging, general-purpose

Device Dossier for Ultrasound system, imaging, general-purpose (Ultrasound system, imaging, general-purpose, Class IIa, sponsor Mindray Medical). ARTG…

Intended purpose

A range of general-purpose diagnostic ultrasound imaging systems designed exclusively for use in a wide variety of both extracorporeal and/or intracorporeal (endosonography or endoscopic) body imaging procedures. These general-purpose systems supports a wide variety of transducers and related application software packages allowing for the collection, display and analysis of ultrasound information. Usages are, e.g. general-purpose imaging, cardiac, OB/GYN, endoscopy, breast, prostate, vascular, intra-surgical, Doppler or colour Doppler, depending on the operating system specific software packages and compatible ultrasound transducers.

TGA Public Summary