PHOTON RADIOSURGERY SYSTEM (PRS)

PHOTON RADIOSURGERY SYSTEM (PRS) is an FDA 510(k)-cleared medical device (K964947) manufactured by Photoelectron Corporation. 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 19, 1997. Regulation: 8.