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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K140235
Device Name XGEO GR40CW
Applicant
Samsung Electronics Co., Ltd.
129, Samsung-Ro
Yeongtong-Gu
Suwon-Si, Gyeonggi-Do,  KR 443742
Applicant Contact JEONGPYO HONG
Correspondent
Samsung Electronics Co., Ltd.
129, Samsung-Ro
Yeongtong-Gu
Suwon-Si, Gyeonggi-Do,  KR 443742
Correspondent Contact JEONGPYO HONG
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/30/2014
Decision Date 05/15/2014
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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