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Truevision Systems, Incorporated
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TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM is an FDA 510(k)-cleared medical device (K101861) manufactured by Truevision Systems, Incorporated. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2010. Regulation: 8.