510(k) · Cleared
Recalled · Class I · 2011Instatrak System with Multiple Dataset Navigation, Model IT3500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Navigation and Visualization IN · LLZ System, Image Processing, Radiological
Cleared on Mar 24, 2004 as substantially equivalent to K020631 (Brainlab AG, 2002) and 1 other predicate after a 72-day review. Its family tree reaches back 2 generations to 1999. 3 of the 287 devices in its family, counting itself, have a Class I recall. 280 later devices descend from it. It has been recalled 6 times, including a Class I recall.
- Decided
- Mar 24, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 6 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983410 (1999). 6 ancestors in all, the oldest K954276 (1996). 280 later devices descend from it, 3 citing it directly. 3 of the 287 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK983410 @ TargetBrainlab AG · 1999
- 1 generation backK020631 IPLANBrainlab AG · 2002
- This deviceK040050 Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004
- Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
- Descendant · 3 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
- Descendant · 4 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
Showing 5 of 280 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 280 · See all- K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
- K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants
- K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · 4 generations on100descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −1 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| 0 (this device) | K040050 | Instatrak System with Multiple Dataset Navigation, Model IT3500 | Ge Medical Systems Navigation and Visualization IN | 2004 | — |
| +1 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| +2 | K121498 | Percunav | Philips Health Care | 2012 | — |
| +3 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| +4 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2016 | 33 |
| +4 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 16 | 0 |
| 2016 | 16 | 0 |
| 2017 | 30 | 0 |
| 2018 | 19 | 0 |
| 2019 | 16 | 0 |
| 2020 | 27 | 0 |
| 2021 | 24 | 0 |
| 2022 | 23 | 0 |
| 2023 | 18 | 0 |
| 2024 | 19 | 0 |
| 2025 | 28 | 2 |
| 2026 | 22 | 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.
3 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020631 | IPLANSummary page 3…ation Multiple Dataset Navigation option on the InstaTrak system is substantially equivalent to the Image Composer application on the Vectorvision iPlan (K020631), manufactured by BrainLAB, and the StealthStation (K954276) with StealthMerge application, manufactured by Medtr… | 2002 |
| * | K954276 | StealthstationSummary page 3…stem is substantially equivalent to the Image Composer application on the Vectorvision iPlan (K020631), manufactured by BrainLAB, and the StealthStation (K954276) with StealthMerge application, manufactured by Medtronic. Each predicate device also offers the capability to fu… | 1996 |
| † | K983529 | Instatrak 3000 | 1998 |
What descends from it? (280)
See all 2803 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 24, 2011 | Not classified | Z-1941-2011 | Component design/selection | Sensor cables may suffer material degradation when exposed to certain sterilization procedures. |
| Feb 24, 2011 | Not classified | Z-1942-2011 | Component design/selection | Sensor cables may suffer material degradation when exposed to certain sterilization procedures. |
| Sep 15, 2006 | Class I | Z-1985-2012 | Software design | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System… |
| Dec 13, 2004 | Not classified | Z-0691-05 | Other | Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised. |
| Sep 15, 2004 | Not classified | Z-0155-05 | Other | Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove. |
| Jul 12, 2004 | Not classified | Z-0815-05 | Other | Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit. |
The 5 latest of 6 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.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K053610 (Traxtal Technologies, Inc., 2006) has gone furthest, with 278 descendants of its own.
- 4 other devices also cite its predicate K020631.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The system is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040050 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040050: Instatrak System with Multiple Dataset Navigation, Model IT3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040050
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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