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Resonance Innovations, LLC
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3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 is an FDA 510(k)-cleared medical device (K061170) manufactured by Resonance Innovations, LLC. 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 24, 2006. Regulation: 8.