PRISM 3000XPV SYSTEM (210714)

PRISM 3000XPV SYSTEM (210714) is an FDA 510(k)-cleared medical device (K961577) manufactured by Philips Medical Systems (Cleveland), 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 July 22, 1996. Regulation: 8.