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E-Woo Technology
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COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D is an FDA 510(k)-cleared medical device (K090171) manufactured by E-Woo Technology. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2009. Regulation: 8.