FDA product code QHA: X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
QHA is the FDA product code for x-ray angiographic imaging based coronary vascular simulation software device. It is a Class II device, regulated under 21 CFR 892.1600 and reviewed by the Radiology panel. FDA has cleared 7 510(k) submissions under QHA, 5 in the last five years, from 5 different applicants. The average 510(k) review took 190 days (median 239); 204 days on average over the last three years.
Definition
X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.
Classification
| Field | Value |
|---|---|
| Device name | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device |
| Device class | Class II |
| Regulation | 21 CFR 892.1600 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QHA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 251 |
| 2021 | 1 | 239 |
| 2023 | 2 | 144 |
| 2024 | 1 | 265 |
| 2025 | 2 | 144 |
Compare with all 510(k) review times · Search every QHA clearance
Top QHA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ArteryFlow Technology Co., Ltd. | 3 | 2023-03-02 |
| Spectrawave, Inc. | 1 | 2025-10-17 |
| Qfr Solutions BV | 1 | 2025-04-04 |
| Pie Medical Imaging BV | 1 | 2024-04-09 |
| Medis Medical Imaging Systems BV | 1 | 2019-05-30 |
Most recent QHA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251355 | Spectrawave, Inc. | X1-FFR | 2025-10-17 | 170 |
| K243769 | Qfr Solutions BV | QFR (3.0) | 2025-04-04 | 119 |
| K232147 | Pie Medical Imaging BV | CAAS Workstation | 2024-04-09 | 265 |
| K230303 | ArteryFlow Technology Co., Ltd. | AccuFFRangio Plus | 2023-03-02 | 27 |
| K221711 | ArteryFlow Technology Co., Ltd. | AccuICAS | 2023-02-28 | 260 |
Recalls for QHA devices
openFDA lists no recalls for product code QHA.
Frequently asked questions
What is FDA product code QHA?
QHA is the FDA product code for x-ray angiographic imaging based coronary vascular simulation software device. It is a Class II device, regulated under 21 CFR 892.1600 and reviewed by the Radiology panel.
What device class is QHA?
Class II, regulation 21 CFR 892.1600. Typical premarket route: 510(k).
How long does a 510(k) take for product code QHA?
Across 7 cleared submissions the average was 190 days from receipt to decision (median 239).
Which companies have the most QHA clearances?
ArteryFlow Technology Co., Ltd. (3); Spectrawave, Inc. (1); Qfr Solutions BV (1); Pie Medical Imaging BV (1); Medis Medical Imaging Systems BV (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QHA
- Run a recall and safety report across every QHA manufacturer
- Watch product code QHA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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