Cardiology
Viz HCM
Viz.ai, Inc.
Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.
FDA Submission Metadata
- Submission number
- DEN230003
- Decision date
- August 2023
- FDA panel
- Cardiovascular
- Product code
- QXO
- Clinical task (npj)
- triage
- 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.
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