Imagio Ultrasound Imaging System

Imagio Ultrasound Imaging System is an FDA 510(k)-cleared medical device (K182628) manufactured by Seno Medical Instruments, 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 4, 2019. Regulation: 8.