PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER

PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER is an FDA 510(k)-cleared medical device (K892358) manufactured by Adac Laboratories. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 1989. Regulation: 8.