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Genoray America, Inc.
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ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K103425) manufactured by Genoray America, 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 March 28, 2011. Regulation: 8.