Cardiology
HeartFlow Analysis
HeartFlow, Inc.
FDA-cleared AI medical device
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
FDA Submission Metadata
- Submission number
- K250902
- Decision date
- July 2025
- FDA panel
- Cardiovascular
- Product code
- PJA
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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