AQUILION PRIME, V5.00

AQUILION PRIME, V5.00 is an FDA 510(k)-cleared medical device (K130645) 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 June 5, 2013. Regulation: 8.