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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K253025
Device Name Ricoh 3D for Healthcare Bolus
Applicant
Ricoh 3D For Healthcare, LLC
5575 Venture Dr.
Unit A
Parma,  OH  44130
Applicant Contact Kim Torluemke
Correspondent
Ricoh 3D For Healthcare, LLC
5575 Venture Dr.
Unit A
Parma,  OH  44130
Correspondent Contact Kim Torluemke
Regulation Number892.5710
Classification Product Code
IXI  
Date Received09/19/2025
Decision Date 04/06/2026
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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