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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, radiation therapy, charged-particle, medical
510(k) Number K120676
Model MEVION S-250
Device Name S-250 PROTON BEAM RADIATION THERAPY SYSTEM
Original Applicant
MEVION MEDICAL SYSTEMS
300 foster st
littleton,  MA  01460
Original Contact thomas h faris
Regulation Number892.5050
Classification Product Code
LHN  
Date Received03/05/2012
Decision Date 06/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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