PHILIPS INTEGRIS V5000 AND BV5000

PHILIPS INTEGRIS V5000 AND BV5000 is an FDA 510(k)-cleared medical device (K973482) manufactured by Philips Medical Systems North America, 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 November 9, 1997. Regulation: 8.