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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K243864
Device Name BONX805
Applicant
BONTECH Co., Ltd.
Digital Empire D-building #1201~1203, 16, Deogyeong-daero
1556beon-gil, Yeongtong-gu
Suwon-si,  KR 16990
Applicant Contact Ki-Chan An
Correspondent
BONTECH Co., Ltd.
Digital Empire D-building #1201~1203, 16, Deogyeong-daero
1556beon-gil, Yeongtong-gu
Suwon-si,  KR 16990
Correspondent Contact Ki-Chan An
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/17/2024
Decision Date 09/12/2025
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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