SonicEye Dual-Array Ultrasound System

SonicEye Dual-Array Ultrasound System is an FDA 510(k)-cleared medical device (K192253) manufactured by Sonivate Medical, 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 24, 2020. Regulation: 8.