# K220306: ECGenius System

- Pathway: 510(k) (Traditional)
- Applicant: Cath Vision Aps
- Decided: May 3, 2022 after 90 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: 7 generations back to K862740 (1986). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183266: EP-TRACER System, Schwarzer Cardiotek GmbH (2019) Summary page 5.

## Most influential descendants
- K223787: ECGenius System (2023), 0 descendants of its own

## Indications for use
The ECGenius™ System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

Source page: https://510kreport.com/device/K220306
Methodology: https://510kreport.com/methodology