SONOSITE EDGE ULTRASOUND SYSTEM

SONOSITE EDGE ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K133454) 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 December 15, 2013. Regulation: 8.