Model note · EP Mapping System
Abbott EnSite X EP System
EnSite X is Abbott's 3D cardiac mapping and catheter navigation system, successor to EnSite Velocity and EnSite Precision. It shows the position of conventional and Sensor Enabled catheters inside the heart, builds a chamber model from collected points, and displays electrical activity as traces and as isopotential and isochronal maps. It can navigate in an impedance based mode or a magnetic primary mode, the latter needing catheters with magnetic sensors.
The model
Maker, model and type.
- Maker
- Abbott Medical (formerly St. Jude Medical)
- Model
- EnSite X EP System
- Device type
- EP Mapping System
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Navigation modes | Magnetic primary mode or impedance based mode (the predicate had impedance only, with magnetic field scaling) | Source |
| Map types | Waveform traces plus 3D isopotential and isochronal maps on a patient specific chamber surface | Source |
| Patient connection modules | SurfaceLink Module, 20 pin and 80 pin Catheter Input Modules, and Direct Connect ports on the amplifier | Source |
| Contact force option | Contact Force Module shows force from compatible catheters when used with TactiSys Quartz equipment | Source |
| Compatible circular mapping catheter (example) | Advisor VL SE: 4 F loop adjustable 15 to 25 mm, 10 or 20 electrodes, two impedance navigation electrodes and two magnetic sensors | Source |
| Software v1.1.1 changes | Undriven patch input signals, composite respiration waveform, bio impedance scaling, respiration gating and metal distortion threshold updates; no hardware change | Source |
| FDA clearance | K202066 (2020) first clearance, product code DQK, 21 CFR 870.1425; reference device CARTO 3 (K180238) | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- The model display must be used together with conventional EP techniques to confirm catheter position. Source
- AutoMarks reflect user set stability and RF or PFA metrics only and do not show lesion effectiveness. Source
- LivePoint displays should not be the only display of tissue proximity during a study. Source
- Ignoring shift and drift detection messages can collect shifted data and contribute to model bloat, according to an Abbott MAUDE investigation. Source
Sources
Where this note comes from.
- FDA 510(k) K202066 summary, EnSite X EP System and Sensor Enabled catheters
- FDA 510(k) K213364 summary, EnSite X v1.1.1
- Abbott EnSite X indications, safety and warnings
- openFDA MAUDE problem counts, brand ENSITE X
Not covered: Amplifier channel counts, field frame specifications, power requirements and the system's error messages are in the Instructions for Use on Abbott's manuals site, which was not read; no error codes are listed. No openFDA recall matched EnSite X. MAUDE counts mix event and malfunction reports and are not failure rates.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
EP Mapping System
Other models of this device.
Next