
Shimadzu Corp.
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SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION is an FDA 510(k)-cleared medical device (K090268) 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 June 29, 2009. Regulation: 8.