Cardiology
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Biosense Webster, Inc.
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K231207
- Decision date
- September 2023
- FDA panel
- Cardiovascular
- Product code
- DQK
- Clinical task (npj)
- detection/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.