ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System

ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System is an FDA 510(k)-cleared medical device (K152469) manufactured by Siemens Medical Solutions, Inc., Ultrasound Division. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 2015. Regulation: 8.