ARTIS pheno (VE30A)

ARTIS pheno (VE30A) is an FDA 510(k)-cleared medical device (K230949) 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 14, 2023. Regulation: 8.