CHISON DIAGNOSTIC ULTRASOUND SYSTEM

CHISON DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K120801) manufactured by Chison Medical Imaging Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2012. Regulation: 8.