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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 K091629
Device Name PROTEUS 235 PROTON THERAPY SYSTEM
Applicant
Ion Beam Applications S.A.
3 Chemin Du Cyclotron
Louvain-La-Neuve, Be-Nota,  BE 1348
Applicant Contact YVES JONGEN
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Regulation Number892.5050
Classification Product Code
LHN  
Date Received06/03/2009
Decision Date 08/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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