# K111818: Sonixgps Needle Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasonix Medical Corporation
- Decided: Jun 13, 2012 after 351 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.
15 later devices descend from it; 2 cite it directly.
6 of 82 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
- K140254: EZONO 4000 (2014), 13 descendants of its own
- K182894: HM70A Diagnostic Ultrasound System (2019), 10 descendants of its own
- K191055: HS40 Diagnostic Ultrasound System (2019), 9 descendants of its own
- K200339: HS40 Diagnostic Ultrasound System (2020), 8 descendants of its own
- K210713: HM70 EVO Diagnostic Ultrasound System (2021), 4 descendants of its own

## Indications for use
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.

Source page: https://510kreport.com/device/K111818
Methodology: https://510kreport.com/methodology