Device Dossier

Ultrasound system, imaging, general-purpose

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

Intended purpose

A general-purpose diagnostic ultrasound imaging system designed exclusively for use in a wide variety of both extracorporeal and/or intracorporeal (endosonography or endoscopic) body imaging procedures. A general-purpose system 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