GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT

GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT is an FDA 510(k)-cleared medical device (K945945) 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 December 21, 1995. Regulation: 8.