
Hitachi Medical Systems America, Inc.
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HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K033248) manufactured by Hitachi Medical Systems America, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 19, 2003. Regulation: 8.