PHILIPS TOMOSCAN SR 8000

PHILIPS TOMOSCAN SR 8000 is an FDA 510(k)-cleared medical device (K954255) 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 October 6, 1995. Regulation: 8.