Cardiology
FFRangio System
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
- K182149
- Decision date
- December 2018
- FDA panel
- Cardiovascular
- Product code
- QEK
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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