SOMATOM On.site and On.scene

SOMATOM On.site and On.scene is an FDA 510(k)-cleared medical device (K193277) 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 21, 2020. Regulation: 8.