ACUSON P500 Ultrasound System

ACUSON P500 Ultrasound System is an FDA 510(k)-cleared medical device (K213487) 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 February 10, 2022. Regulation: 8.