SCEPTREP3 PET/CT

SCEPTREP3 PET/CT is an FDA 510(k)-cleared medical device (K042428) manufactured by Hitachi Medical Systems America, 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 16, 2004. Regulation: 8.