# K131489: Tractus Tissuemapper Image Recording System Application

- Pathway: 510(k) (Traditional)
- Applicant: Tractus Corporation
- Decided: Jun 25, 2013 after 33 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.
2 later devices descend from it; 1 cites it directly.
6 of 69 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 1.

## Most influential descendants
- K171309: BR-FHUS Navigation 1.0 (2017), 1 descendant of its own
- K211098: Breast Volume Navigator (BVN) Model G-2000 (2021), 0 descendants of its own

## Indications for use
The Tractus TissueMapper Image Recording System is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

Source page: https://510kreport.com/device/K131489
Methodology: https://510kreport.com/methodology