QHA · X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Radiology · 21 CFR 892.1600 · Class 2
Overview
| Product Code | QHA |
|---|---|
| Device Name | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device |
| Regulation | 21 CFR 892.1600 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251355 | X1-FFR | Spectrawave, Inc. | Oct 17, 2025 | SESE |
| K243769 | QFR (3.0) | Qfr Solutions BV | Apr 4, 2025 | SESE |
| K232147 | CAAS Workstation | Pie Medical Imaging BV | Apr 9, 2024 | SESE |
| K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | Mar 2, 2023 | SESE |
| K221711 | AccuICAS | ArteryFlow Technology Co., Ltd. | Feb 28, 2023 | SESE |
| K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | Sep 10, 2021 | SESE |
| K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | May 30, 2019 | SESE |
Top Applicants
- ArteryFlow Technology Co., Ltd. — 3 clearances
- Medis Medical Imaging Systems BV — 1 clearance
- Pie Medical Imaging BV — 1 clearance
- Qfr Solutions BV — 1 clearance
- Spectrawave, Inc. — 1 clearance
