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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 K260482
Device Name DRE Duo
Applicant
Jpi Healthcare Co, Ltd.
Woolim E-Biz Center 608-Ho,28, Digital-Ro 33gil, Guro-Gu
Seoul,  KR 08377
Applicant Contact Jeong DoAn
Correspondent
Jpi Healthcare Co, Ltd.
Woolim E-Biz Center 608-Ho,28, Digital-Ro 33gil, Guro-Gu
Seoul,  KR 08377
Correspondent Contact Jeong DoAn
Regulation Number892.1680
Classification Product Code
KPR  
Date Received02/13/2026
Decision Date 06/15/2026
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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