MODIFICATION TO: ON-BOARD IMAGER DEVICE

MODIFICATION TO: ON-BOARD IMAGER DEVICE is an FDA 510(k)-cleared medical device (K041519) 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 3, 2004. Regulation: 8.