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Sectra-Imtec AB
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SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE is an FDA 510(k)-cleared medical device (K040376) 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 May 3, 2004. Regulation: 8.