ARTISTETM SOLUTION WITH SYS VCIO

ARTISTETM SOLUTION WITH SYS VCIO is an FDA 510(k)-cleared medical device (K121295) 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 June 26, 2012. Regulation: 8.