UNISIGHT SYSTEM WITH UNIGATE

UNISIGHT SYSTEM WITH UNIGATE is an FDA 510(k)-cleared medical device (K023394) 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 January 6, 2003. Regulation: 8.