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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
Original Applicant
ION BEAM APPLICATIONS S.A.
3 chemin du cyclotron
louvain-la-neuve, be,  BE 1348
Original Contact yves jongen
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
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