SECTRA WORKSTATION, VERSION 11.1

SECTRA WORKSTATION, VERSION 11.1 is an FDA 510(k)-cleared medical device (K063093) manufactured by Sectra Imtec AB. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2006. Regulation: 8.