SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K041455) manufactured by Sonoscape Company Limited. 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 9, 2004. Regulation: 8.