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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 K053641
Device Name IBA PROTON THERAPY SYSTEM-PROTEUS 235
Applicant
Ion Beam Applications S.A.
Centre Sq. W., 38th Floor
Philadelphia,  PA  19102
Applicant Contact JOHN B REISS
Correspondent
Ion Beam Applications S.A.
Centre Sq. W., 38th Floor
Philadelphia,  PA  19102
Correspondent Contact JOHN B REISS
Regulation Number892.5050
Classification Product Code
LHN  
Date Received12/30/2005
Decision Date 01/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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