ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION

ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION is an FDA 510(k)-cleared medical device (K972879) manufactured by Imatron, 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 14, 1997. Regulation: 8.