HeartFlow Analysis
HeartFlow, Inc.HeartFlow Analysis is a software tool that uses advanced imaging and computational models to simulate coronary vascular physiology. It helps clinicians assess blood flow in the coronary arteries non-invasively, aiding in diagnosis and treatment planning for cardiac patients.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/26/2025
3 months - 2
FDA Approval
7/18/2025
Other devices from HeartFlow, Inc.
- HeartFlow Analysis2022 • 510K
- HeartFlow Analysis2021 • 510K
- HeartFlow FFRct Analysis2019 • 510K
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