# K143396: omni TRAX Active Patient Tracker

- Pathway: 510(k) (Traditional)
- Applicant: Civco Medical Instruments CO Inc Dba Civco Medical Solutions
- Decided: Jan 23, 2015 after 58 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K911783 (1994). 66 ancestors in all.
No later device cites it as a predicate yet.
6 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker, Civco (2009) Summary page 4.

## Indications for use
The device is intended to provide physicians with a tool for electromagnetic (EM) tracking of instruments with respect to pre-acquired or real-time data. The device is intended for use in Magnetic Resonance Imaging (MRI) and ultrasound (US) environments.

Source page: https://510kreport.com/device/K143396
Methodology: https://510kreport.com/methodology