ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System

ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System is an FDA 510(k)-cleared medical device (K150249) 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 March 3, 2015. Regulation: 8.