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Medi-Physics, Inc., Dba GE Healthcare
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BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 is an FDA 510(k)-cleared medical device (K081066) manufactured by Medi-Physics, Inc., Dba GE Healthcare. 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 4, 2008. Regulation: 8.