SonoSite SII Ultrasound System

SonoSite SII Ultrasound System is an FDA 510(k)-cleared medical device (K160734) manufactured by FUJIFILM Sonosite, 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 April 4, 2016. Regulation: 8.