ECAT EXACT & ECAT EXACT HR+

ECAT EXACT & ECAT EXACT HR+ is an FDA 510(k)-cleared medical device (K962797) manufactured by Cti Pet Systems, 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 14, 1996. Regulation: 8.