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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 K152592
Device Name 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 Street NW
WASHINGTON,  DC  20016
Correspondent Contact JONATHAN KAHAN
Regulation Number892.5050
Classification Product Code
LHN  
Date Received09/10/2015
Decision Date 11/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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