Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems is an FDA 510(k)-cleared medical device (K251671) 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 July 2, 2025. Regulation: 8.