510(k) · Cleared
Recalled · Class II · 2023IG4 Image Guided System, Model: Sys-0200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Veran Medical Technologies, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 30, 2009 as substantially equivalent to K060903 (Veran Medical Technologies, Inc., 2006) after a 56-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 30, 2009
- Review
- 56 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001284 (2000). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 1 generation backK060903 IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
- This deviceK093146 IG4 Image Guided System, Model: Sys-0200Veran Medical Technologies, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK093995 IG 4 Image Guided SystemVeran Medical Technologies, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK151414 IQQA GuideEdda Technology · 2015
- Descendant · 3 generations on · 0 of its ownK162314 IMACTIS CT-Navigation systemImactis, Sas · 2018 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −1 | K060903 | IG4 Image Guided System | Veran Medical Technologies, Inc. | 2006 | — |
| 0 (this device) | K093146 | IG4 Image Guided System, Model: Sys-0200 | Veran Medical Technologies, Inc. | 2009 | — |
| +1 | K093995 | IG 4 Image Guided System | Veran Medical Technologies, Inc. | 2010 | — |
| +2 | K151414 | IQQA Guide | Edda Technology | 2015 | — |
| +3 | K162314 | IMACTIS CT-Navigation system | Imactis, Sas | 2018 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 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.
Planning a device in JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K060903 | IG4 Image Guided SystemSummary page 1…stercotactic accessory Classification Name: Computed Tomography X-ray System Classification Code: JAK Equivalent Legally-Marketed Devices: jg4TM Image Guided System (K060903) Device Description: The jg4TM Image Guided System is an accessory for a CT or 3D fluoroscopic x-ray System that utilizes electr… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093995 | IG 4 Image Guided System | 2010 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2023 | Class II | Z-2663-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2661-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2659-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2662-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2664-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K093995 (Veran Medical Technologies, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K060903.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The ig4TM Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4TM System compensates for the patient's respiratory phases.
The ig4TM System is intended for use in clinical interventions and for anatomical structures where computed tomography or 3D fluoroscopic x-ray are currently used for visualizing such procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093146 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093146: IG4 Image Guided System, Model: Sys-0200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093146
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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