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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 Triage And Notification Software
510(k) Number K242292
Device Name uAI Easy Triage ICH
Applicant
Shanghai United Imaging Intelligence Co., Ltd.
# 701 Yunjin Rd., Xuhui District
Shanghai,  CN 200232
Applicant Contact Zhao Xiaojing
Correspondent
Mcra Digital Health
803 7th St., NW, 3rd Floor
Washington, Dc,  DC  20001
Correspondent Contact Nima Akhlaghi
Regulation Number892.2080
Classification Product Code
QAS  
Date Received08/02/2024
Decision Date 09/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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