HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION

HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION is an FDA 510(k)-cleared medical device (K964746) 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 January 23, 1997. Regulation: 8.