Biograph Vision, Biograph mCT Family of PET/CTs

Biograph Vision, Biograph mCT Family of PET/CTs is an FDA 510(k)-cleared medical device (K193248) 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 February 13, 2020. Regulation: 8.