
Sectra Imtec AB
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SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 is an FDA 510(k)-cleared medical device (K081469) 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 June 11, 2008. Regulation: 8.