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Hologic, Inc.
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SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 is an FDA 510(k)-cleared medical device (K062107) 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 17, 2006. Regulation: 8.