# K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker

- Pathway: 510(k) (Traditional)
- Applicant: Civco
- Decided: Nov 13, 2009 after 79 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911783 (1994). 65 ancestors in all.
61 later devices descend from it; 6 cite it directly.
6 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2, Ge Medical Systems Ultrasound and Primary Care Dia (2008) Summary page 2.
- K080624: Navstationirad Emt, Version 1.1, Cas Innovations AG (2008) Summary page 2.
- K040050: Instatrak System with Multiple Dataset Navigation, Model IT3500, Ge Medical Systems Navigation and Visualization IN (2004) Summary page 2.
- K053610: Abaris, Traxtal Technologies, Inc. (2006) Summary page 2.
- K970513: General Purpose Tranducer Cover, CIVCO Medical Instruments Co., Inc. (1997) Summary page 2.
- K974432: Ultraguide 1000, Ultraguide, Ltd. (1998) Summary page 2.
- K002258: Ultraguide CT-Guide 1010, Ultraguide, Ltd. (2000) Summary page 2.
- K882383: Maggi Series Ultra. Needle, Biopsy/Catheter Guides, CIVCO Medical Instruments Co., Inc. (1988) Summary page 2.
- K071204: Site-Rite 6 Ultrasound System, Model Site-Rite 6, C.R. Bard, Inc. (2007) Summary page 2.
- K030064: Ilook 25 Needle Guide Attachment and Bracket Assembly, Sonosite,Inc. (2003) Summary page 2.

## Cited in the summary but kept off the family tree
- K014118: Modification to Supercross Catheter, Abbott Vascular, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K141459: Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 (2014), 39 descendants of its own
- K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0 (2015), 34 descendants of its own
- K161843: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 (2016), 23 descendants of its own
- K163702: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 (2017), 22 descendants of its own
- K173090: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 (2018), 21 descendants of its own

## Recalls of this device
- Mar 2, 2026 · Class II · Z-1738-2026: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interfac
- Mar 2, 2026 · Class II · Z-1736-2026: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interfac
- Mar 2, 2026 · Class II · Z-1731-2026: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interfac
- Mar 2, 2026 · Class II · Z-1735-2026: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interfac
- Mar 2, 2026 · Class II · Z-1732-2026: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interfac
- Mar 2, 2026 · Class II · Z-1737-2026: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interfac
- Mar 2, 2026 · Class II · Z-1734-2026: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interfac
- Mar 2, 2026 · Class II · Z-1733-2026: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interfac
- Oct 8, 2021 · Class II · Z-0395-2022: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- Oct 8, 2021 · Class II · Z-0396-2022: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- Oct 8, 2021 · Class II · Z-0398-2022: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- Oct 8, 2021 · Class II · Z-0397-2022: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- May 7, 2012 · Class II · Z-1956-2012: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
- May 7, 2012 · Class II · Z-1953-2012: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
- May 7, 2012 · Class II · Z-1952-2012: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
- May 7, 2012 · Class II · Z-1955-2012: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
- May 7, 2012 · Class II · Z-1954-2012: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.

## Indications for use
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

Source page: https://510kreport.com/device/K092619
Methodology: https://510kreport.com/methodology