ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM

ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K141641) 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 July 17, 2014. Regulation: 8.