ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems

ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems is an FDA 510(k)-cleared medical device (K163635) manufactured by Siemens Medical Solutions USA, Inc. Ultrasound Group. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 11, 2017. Regulation: 8.