Biosense Webster, Inc. · Class II · Cleared Feb 20, 2026
| K-number | K252972 |
| Device name | CARTO 3 EP Navigation System V8.4 |
| Applicant | Biosense Webster, Inc. |
| Product code | DQK |
| Device class | Class II |
| Decision date | Feb 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
The CARTO™ 3 EP Navigation System V8.4 is a catheter-based cardiac electrophysiological mapping system that acquires and analyzes navigation catheter location and intracardiac ECG signals to display 3D anatomical and electroanatomical maps of the heart. It provides real-time information about cardiac electrical activity and catheter positioning during EP procedures in patients eligible for conventional electrophysiological treatment.
The device has identical intended use, fundamental scientific technology, hardware platform, and magnetic/ACL location mapping technology as the predicate device (CARTO™ 3 V8.1). The primary differences are software enhancements: addition of CARTOSOUND™ REVEAL (an automated ultrasound mapping module with locked AI algorithms) and LA FAM Module (using locked AI for fast anatomical mapping), while the legacy CARTOSOUND FAM Module is no longer supported.
Not stated in this summary.
The CARTO™ 3 System V8.4 is substantially equivalent to the predicate CARTO™ 3 System V8.1 because it maintains identical hardware, the same fundamental location mapping technology with identical accuracy specifications, and identical indications for use. Software enhancements using locked AI algorithms were verified and validated through unit testing, proof of design, functional verification, retrospective clinical validation tests, and animal testing, all of which confirmed the modifications did not negatively affect existing features or raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov