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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 K231467
Device Name 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
Applicant
Rayence Co., Ltd
14, Samsung 1-ro, 1-gil
Hwaseong-si,  KR 18449
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 Received05/22/2023
Decision Date 06/21/2023
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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