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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 K212753
Device Name 0909FCB, 1212FCA
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  
Subsequent Product Code
JAA  
Date Received08/31/2021
Decision Date 10/18/2021
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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