Acuson SC2000 Diagnostic Ultrasound System

Acuson SC2000 Diagnostic Ultrasound System is an FDA 510(k)-cleared medical device (K200585) 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 April 21, 2020. Regulation: 8.