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Shared P.E.T. Imaging, LLC
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CLARITY PET is an FDA 510(k)-cleared medical device (K032866) manufactured by Shared P.E.T. Imaging, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 11, 2003. Regulation: 8.