SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16

SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 is an FDA 510(k)-cleared medical device (K183548) 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 April 14, 2019. Regulation: 8.