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3D Line USA, Inc.
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STEREOTACTIC BODY FRAME, MODEL COD. 70-1A is an FDA 510(k)-cleared medical device (K031631) manufactured by 3D Line USA, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 2003. Regulation: 8.