PROTON BEAM THERAPY SYSTEM (PBTS)

PROTON BEAM THERAPY SYSTEM (PBTS) is an FDA 510(k)-cleared medical device (K992414) manufactured by Optivus Technology, 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 July 20, 2000. Regulation: 8.