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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 K162518
Device Name 1012WCC, 1012WGC
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 Received09/09/2016
Decision Date 10/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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