GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM

GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM is an FDA 510(k)-cleared medical device (K901545) manufactured by Toshiba America Medical Systems, In.C. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 1990. Regulation: 8.