APLIO 500/400/300 V3.0

APLIO 500/400/300 V3.0 is an FDA 510(k)-cleared medical device (K123992) 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 February 5, 2013. Regulation: 8.