
Siemens Medical Solutions USA, Inc., Ultrasound DI
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ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K113179) manufactured by Siemens Medical Solutions USA, Inc., Ultrasound DI. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2011. Regulation: 8.