EchoSure Diagnostic Ultrasound System

EchoSure Diagnostic Ultrasound System is an FDA 510(k)-cleared medical device (K190039) manufactured by Sonavex, 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 March 7, 2019. Regulation: 8.