Device Dossier

Ultrasound system, imaging, general-purpose

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

Intended purpose

This general-purpose diagnostic ultrasound imaging system is intended for use in a wide variety of both extracorporeal and/or intracorporeal(endosonography or endoscopic) body imaging procedures. This general-purpose system is intended to support 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