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Topcon Medical Systems, Inc.
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TRC-50DX RETINAL CAMERA is an FDA 510(k)-cleared medical device (K123101) manufactured by Topcon Medical Systems, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 4, 2013. Regulation: 8.