Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is an FDA 510(k)-cleared medical device (K163688) manufactured by Medisono, LLC. 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 22, 2017. Regulation: 8.