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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
Mtech Group
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
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