PCA-8000A, MARK 11, PET / CT SYSTEM

PCA-8000A, MARK 11, PET / CT SYSTEM is an FDA 510(k)-cleared medical device (K082244) 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 August 20, 2008. Regulation: 8.