SI-1200 / ILUS

SI-1200 / ILUS is an FDA 510(k)-cleared medical device (K911200) manufactured by Siemens Ultrasound, 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 June 16, 1991. Regulation: 8.