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Sectra-Imtec AB
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MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 is an FDA 510(k)-cleared medical device (K033712) 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 December 22, 2003. Regulation: 8.