ORTHORALIX SD/ORTHORALIX SD CEPH

ORTHORALIX SD/ORTHORALIX SD CEPH is an FDA 510(k)-cleared medical device (K890351) 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 June 14, 1989. Regulation: 8.