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Acceletronics Digital Imaging, LLC
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RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER is an FDA 510(k)-cleared medical device (K101038) manufactured by Acceletronics Digital 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 August 16, 2010. Regulation: 8.