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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 K181676
Device Name Mini Ridge Filter and auxiliary functions for PROBEAT-V
Applicant
Hitachi Ltd. Healthcare Hitachi Works
3-1-1, Saiwai-Cho
Hitachi,  JP 317-8511
Applicant Contact Tomoyuki Seino
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20016
Correspondent Contact Jonathan Kahan
Regulation Number892.5050
Classification Product Code
LHN  
Date Received06/25/2018
Decision Date 08/15/2018
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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