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Suni Medical Imaging, Inc.
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X-RAY, TOMOGRAPHY, COMPUTED, DENTAL is an FDA 510(k)-cleared medical device (K083917) manufactured by Suni Medical Imaging, 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 June 1, 2009. Regulation: 8.