510(k) · Cleared
ClearedCT-Guide Needle Guidance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Activiews, Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 21, 2011 as substantially equivalent to K060903 (Veran Medical Technologies, Inc., 2006) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 21, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001284 (2000). 4 ancestors in all. 2 later devices descend from it, 2 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 deviceK110812 CT-Guide Needle Guidance SystemActiviews, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK113063 CT-Guide Needle Guidance SystemActiviews, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK120300 CT-Guide Needle Guidance SystemActiviews, Ltd. · 2012
Most influential descendants
Showing 2 of 2 · 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) | K110812 | CT-Guide Needle Guidance System | Activiews, Ltd. | 2011 | — |
| +1 | K113063 | CT-Guide Needle Guidance System | Activiews, Ltd. | 2011 | — |
| +1 | K120300 | CT-Guide Needle Guidance System | Activiews, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K060903 | IG4 Image Guided SystemSummary page 1…aat Street Haifa 31905 Israel Common or Usual N ame/C lassif ication Name Computed tomography x-ray system accessory Predicate Devices Veran ig4 Image Guided System (K060903) UltraGuide MR Guide 3000 (K01 1418) Intended Use / Indications for Use The CT-Guide is a stereotactic accessory for Computed To… | 2006 |
| * | K011418 | Ultraguide MR-Guide 3000Summary page 1…on or Usual N ame/C lassif ication Name Computed tomography x-ray system accessory Predicate Devices Veran ig4 Image Guided System (K060903) UltraGuide MR Guide 3000 (K01 1418) Intended Use / Indications for Use The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT- Gui… | 2001 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K113063 (Activiews, Ltd., 2011) has gone furthest, with 1 descendant 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. 2011, 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 CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).
The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110812 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110812: CT-Guide Needle Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110812
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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