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Shanghai Chenguang Medical Technologies Co, Ltd.
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MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL is an FDA 510(k)-cleared medical device (K081322) manufactured by Shanghai Chenguang Medical Technologies Co, Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 17, 2008. Regulation: 8.