Device Dossier

Ultrasound system, imaging, general-purpose

Device Dossier for Ultrasound system, imaging, general-purpose (Ultrasound system, imaging, general-purpose, Class IIa, sponsor New Wave Medical WA).…

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 body imaging procedures. These ultrasound systems support a wide variety of transducers and related software 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. Selection of a transducer and associated software enables these different types of examinations.

TGA Public Summary