SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM

SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K984203) manufactured by Shantou Institute of Ultrasonic Instuments. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 31, 1999. Regulation: 8.