CLINIX-R TOMOGRAPHIC DEVICE

CLINIX-R TOMOGRAPHIC DEVICE is an FDA 510(k)-cleared medical device (K810274) 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 March 10, 1981. Regulation: 8.