Radiology
X1-FFR
Spectrawave, Inc.
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.
FDA Submission Metadata
- Submission number
- K251355
- Decision date
- October 2025
- FDA panel
- Radiology
- Product code
- QHA
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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