CT MAX 640 #B7940 JA/JE

CT MAX 640 #B7940 JA/JE is an FDA 510(k)-cleared medical device (K882581) manufactured by General Electric Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 14, 1988. Regulation: 8.