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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
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