510(k) · Cleared
ClearedIG4 Image Guided System
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 May 11, 2006 as substantially equivalent to K002258 (Ultraguide, Ltd., 2000) and 1 other predicate after a 38-day review. Its family tree reaches back 1 generation to 2000. 47 later devices descend from it.
- Decided
- May 11, 2006
- Review
- 38 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001284 (2000). 2 ancestors in all. 47 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- This deviceK060903 IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 27 of its ownK132108 MAXIOPerfint Healthcare Pvt, Ltd. · 2014
- Descendant · 2 generations on · 16 of its ownK150313 Ablation ConfirmationNeuwave Medical, Inc. · 2015
- Descendant · 3 generations on · 11 of its ownK202297 Aline Ablation IntelligenceMirada Medical, Ltd. · 2020
- Descendant · cites it directly · 8 of its ownK083728 Invision SystemInneroptic Technology, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK121479 AIMInneroptic Technology, Inc. · 2012
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K132108MAXIOPerfint Healthcare Pvt, Ltd. · 2014 · cites it directly27descendants
- K150313Ablation ConfirmationNeuwave Medical, Inc. · 2015 · 2 generations on16descendants
- K202297Aline Ablation IntelligenceMirada Medical, Ltd. · 2020 · 3 generations on11descendants
- K083728Invision SystemInneroptic Technology, Inc. · 2009 · cites it directly8descendants
- K121479AIMInneroptic Technology, Inc. · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| 0 (this device) | K060903 | IG4 Image Guided System | Veran Medical Technologies, Inc. | 2006 | — |
| +1 | K132108 | MAXIO | Perfint Healthcare Pvt, Ltd. | 2014 | — |
| +2 | K150313 | Ablation Confirmation | Neuwave Medical, Inc. | 2015 | — |
| +3 | K202297 | Aline Ablation Intelligence | Mirada Medical, Ltd. | 2020 | — |
| +1 | K083728 | Invision System | Inneroptic Technology, Inc. | 2009 | — |
| +2 | K121479 | AIM | Inneroptic Technology, Inc. | 2012 | — |
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 |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K002258 | Ultraguide CT-Guide 1010Summary page 1…izing such procedures. V. Substantial equivalence The ig4TM Image Guided System was demonstrated to be substantially equivalent to the UltraGuide CT-I010 (K002258), the Medtronic Navigation GoldenEye Page 16 ===… | 2000 |
| * | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | 2000 |
| * | — | conventional soft tissue navigation with CT images Named without a submission number |
What descends from it? (47)
See all 477 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132108 | MAXIO | 2014 | 27 |
| K083728 | Invision System | 2009 | 8 |
| K152473 | CAS-One IR | 2016 | 3 |
| K093146 | IG4 Image Guided System, Model: Sys-0200 | 2009 | 3 |
| K110812 | CT-Guide Needle Guidance System | 2011 | 2 |
| K093995 | IG 4 Image Guided System | 2010 | 2 |
| K091934 | IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4… | 2009 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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) Systems. The ig4 System displays an interventional instrument, such as a biopsy needle, an aspiration needle, or an ablation needle, on a computer monitor that also displays a CT-based model of the target organ(s). The ig4 System compensates for the patient's respiratory phases.
The ig4 System is intended to be used in clinical interventions and for anatomical structures where computed tomography is currently used for visualizing such procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060903 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060903: IG4 Image Guided System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060903
Report an extraction error
Are you the manufacturer?
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