Volta AF-Xplorer II is an AI-enabled medical device from Volta Medical, listed by FDA (510(k), K251518) with a decision date of 2025-09-12. Review panel: Cardiovascular.
| FDA submission number | K251518 |
|---|---|
| Pathway | 510(k) |
| Company | Volta Medical |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-09-12 |
| Decision | Substantially Equivalent |
| Product code | DQK |
| Classification | Computer, Diagnostic, Programmable |
| Device class | 2 |
| Regulation number | 870.1425 |
| Review time (calendar days) | 119 |
| Applicant country | FR |
Official FDA database record · FDA AI-enabled device list
More devices from Volta Medical · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.