MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)

MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) is an FDA 510(k)-cleared medical device (K012289) manufactured by Elekta Oncology Systems, Ltd.. 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 13, 2001. Regulation: 8.