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Ge Oec Medical Systems, Inc.
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OEC(R) 9800, OEC(R) 9800 PLUS is an FDA 510(k)-cleared medical device (K111551) manufactured by Ge Oec Medical Systems, 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 October 3, 2011. Regulation: 8.