Cardiology
CorVista® System
CorVista Health, Inc.
FDA-cleared AI medical device
Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up.
FDA Submission Metadata
- Submission number
- K232686
- Decision date
- September 2023
- FDA panel
- Cardiovascular
- Product code
- QXX
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Signals
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.