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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 K152224
Device Name Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
Applicant
Ion Beam Application S.A.
Chemin Du Cycltron 3
Louvain-La-Neuve,  BE 1348
Applicant Contact ANNE-SOPHIE GRELL
Correspondent
Saul Ewing Llp
Center Square W., 1500 Market St., 38th Floor
Philadelphia,  PA  19102 -2186
Correspondent Contact BRUCE D. ARMON
Regulation Number892.5050
Classification Product Code
LHN  
Date Received08/07/2015
Decision Date 08/09/2016
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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