Device Dossier

MyLab - Ultrasound system, imaging, general-purpose

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

Intended purpose

Diagnostic ultrasound imaging system for use in a wide variety of both extracorporeal and/or intracorporeal body imaging procedures. 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. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

TGA Public Summary