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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, Mobile
510(k) Number K222353
Device Name GM85
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 Number892.1720
Classification Product Code
IZL  
Date Received08/04/2022
Decision Date 09/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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