BIOGRAPH TRUE PET/CT FAMILY SOFTWARE

BIOGRAPH TRUE PET/CT FAMILY SOFTWARE is an FDA 510(k)-cleared medical device (K141971) 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 11, 2014. Regulation: 8.