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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K250005
Device Name Clever One
Applicant
Ewoosoft Co., Ltd
801-Ho, Vatechnetworks Bldg., 13, Samsung 1-Ro 2-Gil
Hwaseong-Si,  KR 18449
Applicant Contact Hyeonguk Kang
Correspondent
Ewoosoft Co., Ltd
801-Ho, Vatechnetworks Bldg., 13, Samsung 1-Ro 2-Gil
Hwaseong-Si,  KR 18449
Correspondent Contact Hyeonguk Kang
Regulation Number892.2050
Classification Product Code
QIH  
Date Received01/02/2025
Decision Date 05/23/2025
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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