
Philips Medical Systems North America Co.
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INTEGRIS 3D-RA, RELEASE 4.2 is an FDA 510(k)-cleared medical device (K040254) manufactured by Philips Medical Systems North America Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 18, 2004. Regulation: 8.