SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM

SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM is an FDA 510(k)-cleared medical device (K022858) manufactured by Novasonics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 5, 2002. Regulation: 8.