PHILIPS PIXIUM 4343RC

PHILIPS PIXIUM 4343RC is an FDA 510(k)-cleared medical device (K131483) manufactured by Philips Medical Systems Dmc GmbH. 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 6, 2013. Regulation: 8.