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Hologic, Inc.
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TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 is an FDA 510(k)-cleared medical device (K111508) manufactured by Hologic, 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 August 18, 2011. Regulation: 8.