PHILIPS DIGITAL IMAGING OPTION RELEASE 1

PHILIPS DIGITAL IMAGING OPTION RELEASE 1 is an FDA 510(k)-cleared medical device (K023440) manufactured by Philips Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2002. Regulation: 8.