SSA-770A, APLIO VERSION 5.5

SSA-770A, APLIO VERSION 5.5 is an FDA 510(k)-cleared medical device (K041499) 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 9, 2004. Regulation: 8.