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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 K240411
Device Name uAI Portal
Applicant
Shanghai United Imaging Intelligence Co., Ltd.
No. 701 Yunjin Road, Xuhui District
Shanghai,  CN 200232
Applicant Contact Xiaojing Zhao
Correspondent
Shanghai United Imaging Intelligence Co., Ltd.
No. 701 Yunjin Road, Xuhui District
Shanghai,  CN 200232
Correspondent Contact Xiaojing Zhao
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received02/12/2024
Decision Date 09/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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