SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE is an FDA 510(k)-cleared medical device (K915623) manufactured by Shimadzu 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 February 13, 1992. Regulation: 8.