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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 K253800
Device Name 0909FCE, 0909FCE-HS
Applicant
Rayence Co., Ltd.
14, Samsung 1-Ro 1-Gil
Hwaseong-Si,  KR
Applicant Contact Sung Woo Jung
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 Received11/28/2025
Decision Date 07/31/2026
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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