FUJIFILM SonoSite iViz Ultrasound System

FUJIFILM SonoSite iViz Ultrasound System is an FDA 510(k)-cleared medical device (K152983) 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 November 11, 2015. Regulation: 8.