AccuFFRangio

X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

ArteryFlow Technology Co., Ltd.

The following data is part of a premarket notification filed by Arteryflow Technology Co., Ltd. with the FDA for Accuffrangio.

Pre-market Notification Details

Device IDK210093
510k NumberK210093
Device Name:AccuFFRangio
ClassificationX-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Applicant ArteryFlow Technology Co., Ltd. 459 Qianmo Road, Suite C1-501, Binjiang District Hangzhou,  CN 310051
ContactJianping Xiang
CorrespondentAshley Fu
ArteryFlow Technology Co., Ltd. 459 Qianmo Road, Suite C1-501, Binjiang District Hangzhou,  CN 310051
Product CodeQHA  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-14
Decision Date2021-09-10

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