GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER

GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER is an FDA 510(k)-cleared medical device (K012775) manufactured by GE 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 17, 2001. Regulation: 8.