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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 K161163
Device Name PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
Applicant
Hitachi , Ltd.
2-16-1 Higachi-Ueno
Taito-Ku
Tokyo,  JP 10-0015
Applicant Contact Naoya Nishimura
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20016
Correspondent Contact Jonathan Kahan
Regulation Number892.5050
Classification Product Code
LHN  
Date Received04/25/2016
Decision Date 07/13/2016
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
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