ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM

ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K130619) manufactured by Siemens Medical Solutions USA, 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 March 20, 2013. Regulation: 8.