PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM

PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM is an FDA 510(k)-cleared medical device (K945261) 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 March 20, 1995. Regulation: 8.