Biograph Vision Quadra PET/CT System

Biograph Vision Quadra PET/CT System is an FDA 510(k)-cleared medical device (K210262) 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 March 2, 2021. Regulation: 8.