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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 K261943
Device Name REMEX-T(K)100C
Applicant
Remedi, Inc.
#2f, 69-14, Sakju-Ro 145beon-Gil
Chuncheon-Si, Gangwon-Do, Republic Of Korea
Seoul,  KR 24232
Applicant Contact Seong-Geun Park
Correspondent
Remedi, Inc.
#2f, 69-14, Sakju-Ro 145beon-Gil
Chuncheon-Si, Gangwon-Do, Republic Of Korea
Seoul,  KR 24232
Correspondent Contact Seong-Geun Park
Regulation Number892.1720
Classification Product Code
IZL  
Date Received06/10/2026
Decision Date 10/02/2026
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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