Biograph Vision.X and Biograph Vision.X Edge

Biograph Vision.X and Biograph Vision.X Edge is an FDA 510(k)-cleared medical device (K231833) 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 12, 2023. Regulation: 8.