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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 K213986
Device Name CerebralGo Plus
Applicant
Yukun (Beijing) Technology Co., Ltd
Room 313/315, Building 3, No.11 Chuangxin Road, Science Park
Beijing,  CN 102200
Applicant Contact Wang Qi
Correspondent
Yukun (Beijing) Technology Co., Ltd
Room 313/315, Building 3, No.11 Chuangxin Road, Science Park
Beijing,  CN 102200
Correspondent Contact Wang Qi
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received12/20/2021
Decision Date 04/13/2023
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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