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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K193271
Device Name uAI EasyTriage-Rib
Applicant
Shanghai United Imaging Intelligence Co., Ltd.
# 199 Huanke Rd.
Shanghai,  CN 201210
Applicant Contact Zhao Xiaojing
Correspondent
Shanghai United Imaging Intelligence Co., Ltd.
# 199 Huanke Rd.
Shanghai,  CN 201210
Correspondent Contact Zhao Xiaojing
Regulation Number892.2080
Classification Product Code
QFM  
Date Received11/26/2019
Decision Date 01/15/2021
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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