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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K260093
Device Name Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
Applicant
VATECH Co., Ltd.
13, Samsung 1-Ro 2-Gil
Hwaseong-Si,  KR 18449
Applicant Contact Daniel Kim
Correspondent
Mtech Group, LLC
7505 Fannin St.
Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received01/13/2026
Decision Date 03/31/2026
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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