HAMAMATSU PET SCANNER, MODEL SHR-22000

HAMAMATSU PET SCANNER, MODEL SHR-22000 is an FDA 510(k)-cleared medical device (K982171) manufactured by Hamamatsu Photonics K.K.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 1998. Regulation: 8.