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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
510(k) Number K221711
Device Name AccuICAS
Applicant
ArteryFlow Technology Co., Ltd.
459 Qianmo Rd., Suite C1-501, Binjiang District
Hangzhou City,  CN 310051
Applicant Contact Jianping Xiang
Correspondent
ArteryFlow Technology Co., Ltd.
459 Qianmo Rd., Suite C1-501, Binjiang District
Hangzhou City,  CN 310051
Correspondent Contact Ashley Fu
Regulation Number892.1600
Classification Product Code
QHA  
Subsequent Product Code
LLZ  
Date Received06/13/2022
Decision Date 02/28/2023
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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