ARTIS pheno (VE2)

ARTIS pheno (VE2) is an FDA 510(k)-cleared medical device (K201156) manufactured by Siemens Medical Solution 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 June 28, 2020. Regulation: 8.