
Hologic, Inc.
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APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS is an FDA 510(k)-cleared medical device (K072847) 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 March 27, 2008. Regulation: 8.