510(k) · Cleared
Recalled · Class II · 2017GE Lightspeed Xtra CT Scanner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 19, 2006 as substantially equivalent to K030420 (GE Medical Systems, 2003) after a 103-day review. Its family tree reaches back 2 generations to 2001. 13 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 19, 2006
- Review
- 103 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013561 (2001). 13 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 1 generation backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- This deviceK060052 GE Lightspeed Xtra CT Scanner SystemGe Medical Systems, LLC · 2006
- Descendant · cites it directly · 12 of its ownK082104 GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed…Ge Medical Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 11 of its ownK093581 Discovery Model CT590 RT and Optima Model CT580 CT SystemsGe Medical Systems, LLC · 2011 · Recalled
- Descendant · 3 generations on · 9 of its ownK133640 ASIR-VGe Medical Systems, LLC · 2014
- Descendant · 4 generations on · 8 of its ownK183202 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019
- Descendant · 5 generations on · 2 of its ownK213999 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K082104GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed…Ge Medical Systems, Inc. · 2008 · cites it directly12descendants
- K093581Discovery Model CT590 RT and Optima Model CT580 CT SystemsGe Medical Systems, LLC · 2011 · 2 generations on11descendants
- K133640ASIR-VGe Medical Systems, LLC · 2014 · 3 generations on9descendants
- K183202Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019 · 4 generations on8descendants
- K213999Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −1 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| 0 (this device) | K060052 | GE Lightspeed Xtra CT Scanner System | Ge Medical Systems, LLC | 2006 | — |
| +1 | K082104 | GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 /… | Ge Medical Systems, Inc. | 2008 | 1 |
| +2 | K093581 | Discovery Model CT590 RT and Optima Model CT580 CT Systems | Ge Medical Systems, LLC | 2011 | 4 |
| +3 | K133640 | ASIR-V | Ge Medical Systems, LLC | 2014 | — |
| +4 | K183202 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2019 | — |
| +5 | K213999 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K030420 | Lightspeed 5.0 Computed Tomography SystemSummary page 1…m (21 CFR 892.1750, Product Code JAK) Predicate Device(s): GE LightSpeed 5.0 CT Scanner System K030420 Device Description: The LightSpeed Xtra CT Scanner System is composed of a gantry, patient table, operator console, po… | 2003 |
| † | K013561 | Lightspeed 4.0 CT Scanner System | 2001 |
| † | K002978 | Ligthspeed 3.0 CT Scanner System | 2000 |
| † | K000300 | Lightspeed 2.0CT Scanner System | 2000 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082104 | GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed… | 2008 | 12 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2017 | Class II | Z-2189-2017 | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
| Dec 21, 2006 | Not classified | Z-0805-2007 | Other | Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis. |
| Dec 8, 2006 | Not classified | Z-0506-2007 | Other | When the manual cradle release feature on the table is used to move a patient out of the gantry, a discrepancy of up to 6mm between the numerical display on the gantry and the actual position of the table could be introduced. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K082104 (Ge Medical Systems, Inc., 2008) has gone furthest, with 12 descendants of its own.
- 5 other devices also cite its predicate K030420.
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 GE LightSpeed Xtra CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology.
The system allows imaging of obese patients, up to and including the morbidly obese population (BMI > 40).
When used in the LightSpeed RT Pro 16 configuration:
The system acquires CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060052: GE Lightspeed Xtra CT Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060052
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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