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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 K201042
Device Name PROBEAT-CR
Applicant
Hitachi , Ltd.
2-1, Shintoyufuta
Kashiwa-Shi,  JP 277-0804
Applicant Contact Tomoyuki Seino
Correspondent
Hogan & Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number892.5050
Classification Product Code
LHN  
Date Received04/20/2020
Decision Date 07/13/2020
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
Recalls CDRH Recalls
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