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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 K202722
Device Name 1212FCA
Applicant
Rayence Co., Ltd
14, Samsung 1-ro 1-gil
Hwaseong-si,  KR
Applicant Contact Kee Dock Kim
Correspondent
Mtech Group
7707 Fannin St. Ste. 200
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/17/2020
Decision Date 10/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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