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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K202902
Device Name 2430MCA with Xmaru W
Applicant
Rayence Co., Ltd.
14, Samsung 1-Ro 1-Gil,
Hwaseong-Si,  KR
Applicant Contact Kee Dock Kim
Correspondent
Mtechgroup
7707 Fannin St. Suite 200
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1715
Classification Product Code
MUE  
Subsequent Product Code
LLZ  
Date Received09/29/2020
Decision Date 06/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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