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Advanced Diagnostics, Inc.
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AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) is an FDA 510(k)-cleared medical device (K013886) manufactured by Advanced Diagnostics, 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 May 9, 2002. Regulation: 8.