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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 K201796
Device Name 1717SCV, 1717SGV
Applicant
Rayence Co., Ltd.
14, Samsung 1-Ro 1-Gil,
Hwaseong-Si,  KR
Applicant Contact Kee Dock Kim
Correspondent
Mtechgroup
7707 Fannin St. Suite 200 V111
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/30/2020
Decision Date 07/23/2020
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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