CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is an AI-enabled medical device from Biosense Webster, Inc., listed by FDA (510(k), K231207) with a decision date of 2023-09-07. Review panel: Cardiovascular.
| FDA submission number | K231207 |
|---|---|
| Pathway | 510(k) |
| Company | Biosense Webster, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2023-09-07 |
| Decision | Substantially Equivalent |
| Product code | DQK |
| Classification | Computer, Diagnostic, Programmable |
| Device class | 2 |
| Regulation number | 870.1425 |
| Review time (calendar days) | 133 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.