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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 K152207
Device Name Extended Range Shifter for PROBEAT-V
Applicant
Hitachi, Ltd., Health Care Company
4-14-1 Sotokanda, Chiyoda-Ku
Tokyo,  JP 101-8010
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 Received08/06/2015
Decision Date 10/02/2015
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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