7400 Ultrasound Systems

7400 Ultrasound Systems is an FDA 510(k)-cleared medical device (K190447) manufactured by Navigant Consulting - on Behalf of Esaote S.P.A.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 31, 2019. Regulation: 8.