COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION

COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION is an FDA 510(k)-cleared medical device (K903377) manufactured by Siemens Medical Solutions USA, 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 September 20, 1990. Regulation: 8.