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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, Stationary
510(k) Number K253446
Device Name AeroDR TX c02
Applicant
Dk Medical Systems Co., Ltd.
52, Chupalsandan 1-Gil, Paengseong-Eup
Pyeongtaek-Si,  KR 17998
Applicant Contact Young Woo Kang
Correspondent
KMC, Inc.
#509, Daerung Post Tower, 43, Digital-Ro 26-Gil, Guro-Gu
Seoul,  KR 08389
Correspondent Contact Dong Ha Lee
Regulation Number892.1680
Classification Product Code
KPR  
Date Received10/02/2025
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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