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Xoft, an Icad Company
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AXXENT RADIATION SHIELD - RIGID is an FDA 510(k)-cleared medical device (K111299) manufactured by Xoft, an Icad Company. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 19, 2011. Regulation: 8.