510(k) K221711
- Device
- AccuICAS
- Applicant
- ArteryFlow Technology Co., Ltd.
- 510(k) number
- K221711
- Product code
- QHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-28
- Date received
- 2022-06-13
- Regulation
- 892.1600
- Classification name
- X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Jianping Xiang
- Address
- 459 Qianmo Rd., Suite C1-501, Binjiang District Hangzhou City CN 310051 310051
FDA Registration Numbers
- 9614587
- 3038136528
- 3017654247
- 9710122
Source Documents
Other 510(k) Records For Product Code QHA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251355 | X1-FFR | Spectrawave, Inc. | 2025-10-17 |
| K243769 | QFR (3.0) | Qfr Solutions BV | 2025-04-04 |
| K232147 | CAAS Workstation | Pie Medical Imaging BV | 2024-04-09 |
| K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | 2023-03-02 |
| K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021-09-10 |
| K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019-05-30 |