QFR (3.0)
FDA 510(k) K243769 · Qfr Solutions BV
510(k) numberK243769
Submission
- Device name
- QFR (3.0)
- Applicant
- Qfr Solutions BV
Leiden, NL - Received
- December 6, 2024
- Decision date
- April 4, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QHA – X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1600
- Specialty
- Radiology
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…
Other 510(k)s with product code QHA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251355 | X1-FFRQHA · Traditional | Spectrawave, Inc. | 10/17/2025SE |
| K232147 | CAAS WorkstationQHA · Traditional | Pie Medical Imaging BV | 04/09/2024SE |
| K230303 | AccuFFRangio PlusQHA · Special | ArteryFlow Technology Co., Ltd. | 03/02/2023SE |
| K221711 | AccuICASQHA · Traditional | ArteryFlow Technology Co., Ltd. | 02/28/2023SE |
| K210093 | AccuFFRangioQHA · Traditional | ArteryFlow Technology Co., Ltd. | 09/10/2021SE |
| K182611 | Qangio XA 3DQHA · Traditional | Medis Medical Imaging Systems BV | 05/30/2019SE |
Questions and answers
When was QFR (3.0) cleared by the FDA?
QFR (3.0) (K243769) received a 510(k) decision of Substantially Equivalent on April 4, 2025, 119 days after the submission was received.
What is the product code of K243769?
The FDA product code is QHA – X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device, a Class II (moderate risk) device regulated under 21 CFR 892.1600.