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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 WEST, 1500 MARKET STREET, 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
Recalls CDRH Recalls
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