# K141185: V2.7 Software for the Labsystem Pro EP Recording System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jun 6, 2014 after 30 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: 6 generations back to K000248 (2000). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031000: Labsystem Iii EP Laboratory W/Windows Platform & Windows EP Software Version 1.0, C.R. Bard, Inc. (2003) Summary page 1.
- K113811: V2.6 Software for the Labsystem Pro EP Recording System, C.R. Bard Inc., Bard Electrophysiology Division (2012) Summary page 2.

## Most influential descendants
- K230008: Ablamap® System (2023), 1 descendant of its own
- K251344: OptiMap™ System (2025), 0 descendants of its own

## Indications for use
The LabSystem EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data. When integrated with the Biosense Webster CARTO 3 system, the Bard LabSystem PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster CARTO 3, and b) acquire (from Biosense Webster CARTO 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster CARTO 3 device and stored on the Bard LabSystem PRO EP Recording System for review and insertion into the final clinical report. Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.

Source page: https://510kreport.com/device/K141185
Methodology: https://510kreport.com/methodology