
Shimadzu Corp.
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SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION is an FDA 510(k)-cleared medical device (K080701) manufactured by Shimadzu Corp.. 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 13, 2008. Regulation: 8.