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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 K210985
Device Name 1717FCC
Applicant
Rayence Co., Ltd
14, Samsung 1-ro, 1-gil
hwaseong-si,  KR 445-170
Applicant Contact kevin kim
Correspondent
Mtech Group
7505 Fannin St. Ste 610
houston,  TX  77054
Correspondent Contact dave kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/01/2021
Decision Date 04/28/2021
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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