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Cti Pet Systems, Inc.
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LSO PET/CT HIREZ 64 is an FDA 510(k)-cleared medical device (K042467) 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 September 30, 2004. Regulation: 8.