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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K252717
Device Name MAASTRO Rectal Applicator Set
Applicant
Varian Medical Systems
3100 Hansen Way
Palo Alto,  CA  94304
Applicant Contact Lynn Allman
Correspondent
Varian Medical Systems
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact Lynn Allman
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received08/28/2025
Decision Date 05/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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