X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
The X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device is a prescription software device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data, solving algorithms to yield simulation-based metrics for cardiology applications; it cannot be used alone for clinical decision making and is intended to generate results for review by a qualified clinician. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 892.1600 in the Radiology specialty. The product code is QHA. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QHA
- Device Class
- FDA class 2
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251355 | X1-FFR | Oct 17, 2025 | Substantially Equivalent | Spectrawave, Inc. |
| K243769 | QFR (3.0) | Apr 04, 2025 | Substantially Equivalent | Qfr Solutions BV |
| K232147 | CAAS Workstation | Apr 09, 2024 | Substantially Equivalent | Pie Medical Imaging BV |
| K230303 | AccuFFRangio Plus | Mar 02, 2023 | Substantially Equivalent | ArteryFlow Technology Co., Ltd. |
| K221711 | AccuICAS | Feb 28, 2023 | Substantially Equivalent | ArteryFlow Technology Co., Ltd. |
| K210093 | AccuFFRangio | Sep 10, 2021 | Substantially Equivalent | ArteryFlow Technology Co., Ltd. |
| K182611 | Qangio XA 3D | May 30, 2019 | Substantially Equivalent | Medis Medical Imaging Systems BV |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.