
Cti Pet Systems, Inc.
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ECAT VISION PET SCANNER, MODELS 3000 & 5000 is an FDA 510(k)-cleared medical device (K021633) 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 August 13, 2002. Regulation: 8.