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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 K171417
Device Name 1417WGC_127um and 1417WGC_140um
Applicant
Rayence Co., Ltd.
14, Samsung 1-Ro, 1-Gil
Hwaseong-Si,  KR 445-170
Applicant Contact Kevin Kim
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/15/2017
Decision Date 06/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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