FDA clears Perception ultrasound unit

November 12, 1997

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

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.