Viz HCM is an AI-enabled medical device from Viz.ai, Inc., listed by FDA (De Novo, DEN230003) with a decision date of 2023-08-03. Review panel: Cardiovascular.
| FDA submission number | DEN230003 |
|---|---|
| Pathway | De Novo |
| Company | Viz.ai, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2023-08-03 |
| Decision | Unknown |
| Product code | QXO |
| Classification | Cardiovascular Machine Learning-Based Notification Software |
| Device class | 2 |
| Regulation number | 870.2380 |
| Review time (calendar days) | 205 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Viz.ai, Inc. · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.