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Omega Medical Imaging, Inc.
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CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) is an FDA 510(k)-cleared medical device (K070834) manufactured by Omega Medical Imaging, 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 May 17, 2007. Regulation: 8.