ZONARE ULTRA ULTRASOUND SYSTEM

ZONARE ULTRA ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K082326) 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 October 7, 2008. Regulation: 8.