COMPUTED TOMOGRAPHY X-RAY SYSTEM

COMPUTED TOMOGRAPHY X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K102196) manufactured by VATECH Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 2011. Regulation: 8.