LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ

LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ is an FDA 510(k)-cleared medical device (K033431) manufactured by Cti Pet Systems, 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 November 19, 2003. Regulation: 8.