SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000

SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000 is an FDA 510(k)-cleared medical device (K042369) 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 October 19, 2004. Regulation: 8.