Somatom Confidence ® RT Pro

Somatom Confidence ® RT Pro is an FDA 510(k)-cleared medical device (K162302) 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 December 15, 2016. Regulation: 8.