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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K260481
Device Name GC85A
Applicant
Samsung Electronics Co., Ltd.
129 Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Applicant Contact Jaesang NOH
Correspondent
Samsung Electronics Co., Ltd.
129 Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Correspondent Contact Jaesang NOH
Regulation Number892.1680
Classification Product Code
KPR  
Date Received02/13/2026
Decision Date 08/27/2026
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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