FDA clears Perception ultrasound unit

Perception Ultrasound of Miami has received 510(k) clearance from the Food and Drug Administration for its Perception 5000 PC-based ultrasound scanner, which is based on Windows NT and uses software rather than hardware to control system parameters. The system will be targeted at ob/gyn, vascular, urology, family practice, and emergency room applications. It will carry an average selling price of $40,000 and will be sold in the U.S. through direct sales and dealers.

Perception 5000 is the first Perception scanner to receive 510(k) clearance. Other systems include the Perception 2500, a portable scanner for which 510(k) clearance is pending, and Bak-Pac, a portable battery-powered system under development that will be sold to the military.