APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0

APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 is an FDA 510(k)-cleared medical device (K133761) manufactured by Toshibamedical Systems Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 21, 2014. Regulation: 8.