The following data is part of a premarket notification filed by Arteryflow Technology Co., Ltd. with the FDA for Accuffrangio.
| Device ID | K210093 |
| 510k Number | K210093 |
| Device Name: | AccuFFRangio |
| Classification | X-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 |
| Contact | Jianping Xiang |
| Correspondent | Ashley Fu ArteryFlow Technology Co., Ltd. 459 Qianmo Road, Suite C1-501, Binjiang District Hangzhou, CN 310051 |
| Product Code | QHA |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-14 |
| Decision Date | 2021-09-10 |