1. FDA Food and Drug Administration MD 2. 1980 Therace25 X 3. 2001 1 62 4. 006 5 007 1 1 MID IS014971 JIS T14971 5. IMPT Intensity Modulated Particle Therapy 6. IPEJ JOurnal Vol 22 NO 7. e mail kazuo tomida zf hitachi com 63 8. 6010 8 Pp _ TT II Regulatory Compliance and Risk Management for the State of the Art Proton Beam Therapy Sysfem 1895 X CT Computed Tomography PET Positron Emission Tomography X CT PET