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Imix Adr Finland OY
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IMIX PANORAD AND SOMARAD is an FDA 510(k)-cleared medical device (K101435) manufactured by Imix Adr Finland OY. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2010. Regulation: 8.