NAEOTOM Alpha, Scan&GO

NAEOTOM Alpha, Scan&GO is an FDA 510(k)-cleared medical device (K211591) 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 September 29, 2021. Regulation: 8.