
Cti Pet Systems, Inc.
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LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I is an FDA 510(k)-cleared medical device (K050509) 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 March 24, 2005. Regulation: 8.