SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System

SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System is an FDA 510(k)-cleared medical device (K162045) 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 August 17, 2016. Regulation: 8.