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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 K260085
Device Name RAYMO Mobile X-ray System (Model: RAYMO)
Applicant
DRGEM Corporation
7f, E-B/D Gwangmyeong Techno-Park 60, Haan-Ro
Gwangmyeong-Si,  KR 14322
Applicant Contact Yubin CHO
Correspondent
DRGEM Corporation
7f, E-B/D Gwangmyeong Techno-Park 60, Haan-Ro
Gwangmyeong-Si,  KR 14322
Correspondent Contact Yubin CHO
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received01/12/2026
Decision Date 05/14/2026
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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