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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 K220883
Device Name Small Field Applicator
Applicant
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
226-44-141-1, Wakashiba
Kashiwa-Shi,  JP 277-0871
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 Received03/25/2022
Decision Date 12/15/2022
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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