ACUSON Freestyle Diagnostic Ultrasound System

ACUSON Freestyle Diagnostic Ultrasound System is an FDA 510(k)-cleared medical device (K200644) 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 9, 2020. Regulation: 8.