Z.ONE ULTRA ULTRASOUND SYSTEM

Z.ONE ULTRA ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K101091) manufactured by Zonare Medical Systems, 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 June 24, 2010. Regulation: 8.