PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION

PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION is an FDA 510(k)-cleared medical device (K934722) manufactured by Ohio Imaging, 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 May 12, 1994. Regulation: 8.