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E-Woo Technology
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DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 is an FDA 510(k)-cleared medical device (K091090) 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 August 8, 2010. Regulation: 8.