# K140497: Ecvue Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Cardioinsight Technologies, Inc.
- Decided: Nov 19, 2014 after 265 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.
8 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113811: V2.6 Software for the Labsystem Pro EP Recording System, C.R. Bard Inc., Bard Electrophysiology Division (2012) Summary page 4.

## Most influential descendants
- K150990: ECVUE Mapping System (2015), 7 descendants of its own
- K162440: CardioInsight Cardiac Mapping System (2016), 6 descendants of its own
- K181918: CardioInsight Cardiac Mapping System (2018), 2 descendants of its own
- K211546: Vektor Computational ECG Mapping System (vMap) (2021), 1 descendant of its own
- K183195: VIVO (2019), 1 descendant of its own

## Indications for use
The CardioInsight ECVUE Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

Source page: https://510kreport.com/device/K140497
Methodology: https://510kreport.com/methodology