# K201148: EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Jun 26, 2020 after 58 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K000248 (2000). 34 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183128: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2, Abbott (2018) Summary page 5.

## Most influential descendants
- K241828: Affera Integrated Mapping System; Impedance Localization Patch Kit (2024), 4 descendants of its own
- K243892: Affera Integrated Mapping System (2025), 1 descendant of its own
- K262005: Affera Integrated Mapping System (2026), 0 descendants of its own
- K250747: Globe® Pulsed Field System (2025), 0 descendants of its own
- K243435: Magnetic Localization Patch Kit (AFR-00021) (2024), 0 descendants of its own

## Indications for use
EnSite™ Velocity™ Cardiac Mapping System v5.2: The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. When used with the EnSite™ Array™ Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. or When used with an EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart. EnSite Precision™ Cardiac Mapping System v2.6: The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. or When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart. EnSite™ Verismo™ Segmentation Tool: The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System. EnSite™ Derexi™ Module: When used with EnSite™ Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information. EnSite™ Courier™ Module: When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server. EnSite™ Fusion™ Registration Module: EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers. EnSite™ Contact Force Module: When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters. EnSite™ AutoMap Module: When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user. AutoMark Module: When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.

Source page: https://510kreport.com/device/K201148
Methodology: https://510kreport.com/methodology