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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 K123098
Device Name XGEO GC80
Applicant
Samsung Electronics Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Applicant Contact CHARLIE MACK
Correspondent
Samsung Electronics Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Correspondent Contact CHARLIE MACK
Regulation Number892.1680
Classification Product Code
KPR  
Date Received10/02/2012
Decision Date 01/18/2013
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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