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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 K171049
Device Name Real Time Image Gating System for Proton Beam Therapy Systems
Applicant
Hitachi, Ltd. Healthcare
2-16-1 Higachi-Ueno, Taito-Ku
Tokyo,  JP
Applicant Contact Tomoyuki Seino
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20016
Correspondent Contact Jonathan Kahan
Regulation Number892.5050
Classification Product Code
LHN  
Date Received04/07/2017
Decision Date 12/26/2017
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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