CADPLAN HELIOS OPTION 6.0

CADPLAN HELIOS OPTION 6.0 is an FDA 510(k)-cleared medical device (K984532) manufactured by Varian Medical Systems, 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 August 8, 1999. Regulation: 8.