| K-number | K252013 |
| Device name | EnSite X EP System |
| Applicant | ABBOTT MEDICAL |
| Product code | DQK |
| Device class | Class II |
| Decision date | Sep 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
The EnSite X EP System is a diagnostic computer system used by electrophysiology specialists during cardiac electrophysiology studies. It displays information about the heart's electrical activity and shows catheter location during EP procedures. When used with compatible catheters and equipment, it can also visualize contact force information.
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The device is classified as a Class II programmable diagnostic computer (product code DQK) and is substantially equivalent to legally marketed predicate devices. The submission demonstrates equivalence through the indications for use, intended use, and functional characteristics without introduction of new safety or effectiveness concerns requiring additional premarket review.
View the full FDA submission: accessdata.fda.gov