Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT is an FDA 510(k)-cleared medical device (K162736) 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 October 24, 2016. Regulation: 8.