Device Dossier

General ultrasound imaging system, battery-powered

Device Dossier for General ultrasound imaging system, battery-powered (General ultrasound imaging system, battery-powered, Class IIa, sponsor GE…

Intended purpose

Thisbattery-powered, hand-held assembly of devices is intended for collection, display, and analysis of ultrasound information during a variety of extracorporeal ultrasound imaging procedures (i.e., non-dedicated); it is not intended for intracorporeal ultrasound imaging. It typically consists of an ultrasound transducer, data processing unit, and graphical display contained within a compact unit, and may include a line-powered charging station.

TGA Public Summary