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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 K133191
Device Name PROBEAM PROTON THERAPY SYSTEM
Applicant
Varian Medical Systems
3100 Hansen Way
Palo Alto,  CA  94304 -1129
Applicant Contact VY TRAN
Correspondent
Varian Medical Systems
3100 Hansen Way
Palo Alto,  CA  94304 -1129
Correspondent Contact VY TRAN
Regulation Number892.5050
Classification Product Code
LHN  
Date Received10/17/2013
Decision Date 01/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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