ExactVu system - Ultrasound system, imaging, general-purpose

Intended purpose

A mobile assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures . The ExactVu micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use (clinical applications) are: • Small Organ • Transrectal • Abdominal The system may be used with patients of all ages, but is not designed for pediatric or fetal use. The system is contraindicated for direct cardiac application and for ophthalmic use or any application that causes the acoustic beam to pass through the eye.