Cardiology
CARTO 3 EP Navigation System V8.4
Biosense Webster, Inc.
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K252972
- Decision date
- February 2026
- FDA panel
- Cardiovascular
- Product code
- DQK
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.