Cardiology
FFRangio
CathWorks Ltd
FDA-cleared AI medical device
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
FDA Submission Metadata
- Submission number
- K192442
- Decision date
- December 2019
- FDA panel
- Cardiovascular
- Product code
- QEK
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Images
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.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.