510(k) · Cleared
Recalled · Class II · 2026Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Civco · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 13, 2009 as substantially equivalent to K082185 (Ge Medical Systems Ultrasound and Primary Care Dia, 2008) and 9 other predicates after a 79-day review. Its family tree reaches back 6 generations to 1994. 6 of the 127 devices in its family, counting itself, have a Class I recall. 61 later devices descend from it. It has been recalled 17 times.
- Decided
- Nov 13, 2009
- Review
- 79 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 17
- Predicates
- 11
Its longest line of descent runs back 6 generations to K911783 (1994). 65 ancestors in all, the oldest K844472 (1985). 61 later devices descend from it, 6 citing it directly. 6 of the 127 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 5 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 4 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 3 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 2 generations backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- 1 generation backK080624 Navstationirad Emt, Version 1.1Cas Innovations AG · 2008
- This deviceK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009
- Descendant · cites it directly · 39 of its ownK141459 Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation · 2014
- Descendant · 2 generations on · 34 of its ownK151451 Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 3 generations on · 23 of its ownK161843 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation · 2016 · Recalled
- Descendant · 3 generations on · 22 of its ownK163702 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation · 2017 · Recalled
- Descendant · 4 generations on · 21 of its ownK173090 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation · 2018
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
2011high 8 (2020) · low 1 (2011)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 61 · See all- K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation · 2014 · cites it directly39descendants
- K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · 2 generations on34descendants
- K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation · 2016 · 3 generations on23descendants
- K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation · 2017 · 3 generations on22descendants
- K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation · 2018 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −5 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −4 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −3 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −2 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| −1 | K080624 | Navstationirad Emt, Version 1.1 | Cas Innovations AG | 2008 | — |
| 0 (this device) | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax… | Civco | 2009 | — |
| +1 | K141459 | Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 | Toshibamedical Systems Corporation | 2014 | — |
| +2 | K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2015 | 2 |
| +3 | K161843 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 | Toshibamedical Systems Corporation | 2016 | 1 |
| +3 | K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 | Toshibamedical Systems Corporation | 2017 | 1 |
| +4 | K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 | Toshibamedical Systems Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 1 |
| 1997 | 3 | 0 |
| 1998 | 7 | 1 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 1 |
| 2005 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (11)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082185 | GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Summary page 2…g when combined with appropriate software delivered in the OEM equipment. Predicate Devices: The following predicate devices were referenced in the submission. K082185 - GE Medical Systems, GE Logiq E9 Diagnostic Ultrasound System K080624 - CAS Innovation AG, NavStation / RAD EMT K040050 - InstaT… | 2008 |
| * | K080624 | Navstationirad Emt, Version 1.1Summary page 2…quipment. Predicate Devices: The following predicate devices were referenced in the submission. K082185 - GE Medical Systems, GE Logiq E9 Diagnostic Ultrasound System K080624 - CAS Innovation AG, NavStation / RAD EMT K040050 - InstaTrack with Multiple Dataset Navigation K053610 - ABARIS Computer assiste… | 2008 |
| * | K040050 | Instatrak System with Multiple Dataset Navigation, Model IT3500Summary page 2…cate devices were referenced in the submission. K082185 - GE Medical Systems, GE Logiq E9 Diagnostic Ultrasound System K080624 - CAS Innovation AG, NavStation / RAD EMT K040050 - InstaTrack with Multiple Dataset Navigation K053610 - ABARIS Computer assisted, image-guided surgery system K970513 - Poly ultr… | 2004 |
| * | K053610 | AbarisSummary page 2…85 - GE Medical Systems, GE Logiq E9 Diagnostic Ultrasound System K080624 - CAS Innovation AG, NavStation / RAD EMT K040050 - InstaTrack with Multiple Dataset Navigation K053610 - ABARIS Computer assisted, image-guided surgery system K970513 - Poly ultrasound probe cover K974432, KOI 1418, K002258 - UltraG… | 2006 |
| * | K970513 | General Purpose Tranducer CoverSummary page 2…m K080624 - CAS Innovation AG, NavStation / RAD EMT K040050 - InstaTrack with Multiple Dataset Navigation K053610 - ABARIS Computer assisted, image-guided surgery system K970513 - Poly ultrasound probe cover K974432, KOI 1418, K002258 - UltraGuide K882383 - Maggi ultrasound needle guide K071204 - SiteRite… | 1997 |
| * | K974432 | Ultraguide 1000Summary page 2…ion / RAD EMT K040050 - InstaTrack with Multiple Dataset Navigation K053610 - ABARIS Computer assisted, image-guided surgery system K970513 - Poly ultrasound probe cover K974432, KOI 1418, K002258 - UltraGuide K882383 - Maggi ultrasound needle guide K071204 - SiteRite 6 Ultrasound System and guide K030064… | 1998 |
| Kept off the family tree | K014118 | FDA’s K014118 is Modification to Supercross Catheter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
| * | K002258 | Ultraguide CT-Guide 1010Summary page 2…50 - InstaTrack with Multiple Dataset Navigation K053610 - ABARIS Computer assisted, image-guided surgery system K970513 - Poly ultrasound probe cover K974432, KOI 1418, K002258 - UltraGuide K882383 - Maggi ultrasound needle guide K071204 - SiteRite 6 Ultrasound System and guide K030064 - iLook 25 Needle G… | 2000 |
| * | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter GuidesSummary page 2…Multiple Dataset Navigation K053610 - ABARIS Computer assisted, image-guided surgery system K970513 - Poly ultrasound probe cover K974432, KOI 1418, K002258 - UltraGuide K882383 - Maggi ultrasound needle guide K071204 - SiteRite 6 Ultrasound System and guide K030064 - iLook 25 Needle Guide attachment and B… | 1988 |
| * | K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6Summary page 2…ARIS Computer assisted, image-guided surgery system K970513 - Poly ultrasound probe cover K974432, KOI 1418, K002258 - UltraGuide K882383 - Maggi ultrasound needle guide K071204 - SiteRite 6 Ultrasound System and guide K030064 - iLook 25 Needle Guide attachment and Bracket Assembly Substantial Equivalenc… | 2007 |
| * | K030064 | Ilook 25 Needle Guide Attachment and Bracket AssemblySummary page 2…em K970513 - Poly ultrasound probe cover K974432, KOI 1418, K002258 - UltraGuide K882383 - Maggi ultrasound needle guide K071204 - SiteRite 6 Ultrasound System and guide K030064 - iLook 25 Needle Guide attachment and Bracket Assembly Substantial Equivalence: CIVCO Medical Instruments claims the proposed… | 2003 |
What descends from it? (61)
See all 616 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141459 | Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 | 2014 | 39 |
| K111818 | Sonixgps Needle Sensor | 2012 | 15 |
| K131489 | Tractus Tissuemapper Image Recording System Application | 2013 | 2 |
| K143396 | omni TRAX Active Patient Tracker | 2015 | 0 |
| K133901 | Pari-Path Surgical Navigation System | 2014 | 0 |
| K113680 | Soma Access Systems Exacttrack Procedure Kit | 2011 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 2, 2026 | Class II | Z-1738-2026 | Software change control | 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 interface. |
| Mar 2, 2026 | Class II | Z-1736-2026 | Software change control | 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 interface. |
| Mar 2, 2026 | Class II | Z-1731-2026 | Software change control | 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 interface. |
| Mar 2, 2026 | Class II | Z-1735-2026 | Software change control | 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 interface. |
| Mar 2, 2026 | Class II | Z-1732-2026 | Software change control | 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 interface. |
| Mar 2, 2026 | Class II | Z-1737-2026 | Software change control | 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 interface. |
| Mar 2, 2026 | Class II | Z-1734-2026 | Software change control | 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 interface. |
| Mar 2, 2026 | Class II | Z-1733-2026 | Software change control | 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 interface. |
| Oct 8, 2021 | Class II | Z-0395-2022 | Device Design | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |
| Oct 8, 2021 | Class II | Z-0396-2022 | Device Design | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |
| Oct 8, 2021 | Class II | Z-0398-2022 | Device Design | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |
| Oct 8, 2021 | Class II | Z-0397-2022 | Device Design | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |
| May 7, 2012 | Class II | Z-1956-2012 | Component design/selection | 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 | Component design/selection | 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 | Component design/selection | 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 | Component design/selection | 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 | Component design/selection | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. |
The 5 latest of 17 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 21 of the 65 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K141459 (Toshibamedical Systems Corporation, 2014) has gone furthest, with 39 descendants of its own.
- 7 other devices also cite its predicate K082185.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2007high 20 (2007) · low 5 (2022)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
2007high 220 (2024) · low 17 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
2007high 11 (2021) · low 0 (2011)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
2007high 640 (2024) · low 20 (2008)2025
MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092619 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092619
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026