UNIWEB, VERSION 5.0

UNIWEB, VERSION 5.0 is an FDA 510(k)-cleared medical device (K071166) manufactured by Electronic Business Machine Co., Ltd. (Ebm). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 2007. Regulation: 8.