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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 K232032
Device Name PROBEAT-FR
Applicant
Hitachi Ltd., Radiation Oncology Systems, Kashiwanoha
226-44-141-1, Wakashiba
Kashiwa-Shi,  JP 277-0871
Applicant Contact Tomoko Irisa
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Lina Kontos
Regulation Number892.5050
Classification Product Code
LHN  
Date Received07/07/2023
Decision Date 01/12/2024
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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