CLINICAL PROTON SPECTROSCOPY OPTION

CLINICAL PROTON SPECTROSCOPY OPTION is an FDA 510(k)-cleared medical device (K951650) manufactured by Siemens Medical Solutions USA, 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 November 13, 1995. Regulation: 8.