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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 K150150
Device Name 1717SGN / 1717SCN Digital Flat Panel X-ray Detector
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 Received01/23/2015
Decision Date 03/27/2015
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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