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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 K240371
Device Name 0909FCC, 0909FCC-HS
Applicant
Rayence Co., Ltd.
14, Samsung 1-Ro 1-Gil
Hwaseong-Si,  KR 18449
Applicant Contact Inhwan Bang
Correspondent
Mtech Group, LLC
7505 Fannin St.
Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
JAA  
Date Received02/07/2024
Decision Date 03/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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