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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K221627
Device Name PerfusionGo Plus
Applicant
Yukun (Beijing) Technology Co., Ltd.
Room 313, 315, Building 3, No.11 Chuangxin Road,
Science Park, Changping District
Beijing,  CN 102200
Applicant Contact Qi Wang
Correspondent
Yukun (Beijing) Technology Co., Ltd.
Room 313, 315, Building 3, No.11 Chuangxin Road,
Science Park, Changping District
Beijing,  CN 102200
Correspondent Contact Qi Wang
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/06/2022
Decision Date 01/19/2023
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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