PET-SCOPE II MODEL DIS-1611

PET-SCOPE II MODEL DIS-1611 is an FDA 510(k)-cleared medical device (K801166) manufactured by Diagnostic Information, 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 June 25, 1980. Regulation: 8.