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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K260479
Device Name TheraSphere 360™ Y-90 Management Platform
Applicant
Boston Scientific Corporation
300 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Amy McKinney
Correspondent
Boston Scientific Corporation
300 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Amy McKinney
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/13/2026
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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