
Hologic, Inc.
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INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K120388) 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 April 5, 2012. Regulation: 8.