
Ge Oec Medical Systems
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OEC FLUOROTRAK 9800 PLUS is an FDA 510(k)-cleared medical device (K022069) manufactured by Ge Oec Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 2002. Regulation: 8.