510(k) · Cleared
Recalled · Class II · 2017GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed Xtra CT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 2, 2008 as substantially equivalent to K060052 (Ge Medical Systems, LLC, 2006) after a 39-day review. Its family tree reaches back 3 generations to 2001. 12 later devices descend from it. It has been recalled once.
- Decided
- Sep 2, 2008
- Review
- 39 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013561 (2001). 12 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 2 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 1 generation backK060052 GE Lightspeed Xtra CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- This deviceK082104 GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed…Ge Medical Systems, Inc. · 2008
- Descendant · cites it directly · 11 of its ownK093581 Discovery Model CT590 RT and Optima Model CT580 CT SystemsGe Medical Systems, LLC · 2011 · Recalled
- Descendant · 2 generations on · 9 of its ownK133640 ASIR-VGe Medical Systems, LLC · 2014
- Descendant · 3 generations on · 8 of its ownK183202 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019
- Descendant · 4 generations on · 2 of its ownK213999 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022
- Descendant · 4 generations on · 1 of its ownK193170 Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K093581Discovery Model CT590 RT and Optima Model CT580 CT SystemsGe Medical Systems, LLC · 2011 · cites it directly11descendants
- K133640ASIR-VGe Medical Systems, LLC · 2014 · 2 generations on9descendants
- K183202Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019 · 3 generations on8descendants
- K213999Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022 · 4 generations on2descendants
- K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −2 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −1 | K060052 | GE Lightspeed Xtra CT Scanner System | Ge Medical Systems, LLC | 2006 | 3 |
| 0 (this device) | K082104 | GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 /… | Ge Medical Systems, Inc. | 2008 | — |
| +1 | K093581 | Discovery Model CT590 RT and Optima Model CT580 CT Systems | Ge Medical Systems, LLC | 2011 | 4 |
| +2 | K133640 | ASIR-V | Ge Medical Systems, LLC | 2014 | — |
| +3 | K183202 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2019 | — |
| +4 | K213999 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2022 | — |
| +4 | K193170 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K060052 | GE Lightspeed Xtra CT Scanner SystemSummary page 2…5-2 Predicate Device(s): GE LightSpeed Xtra CT Scanner System (K060052) DEVICE DESCRIPTION The GE LightSpeed RT16 / LightSpeed Xtra V2 (aka LightSpeed RT16 /LightSpeed Xtra CT) CT Scanner System is c… | 2006 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093581 | Discovery Model CT590 RT and Optima Model CT580 CT Systems | 2011 | 11 |
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K093581 (Ge Medical Systems, LLC, 2011) has gone furthest, with 11 descendants of its own.
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. 2008, 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 GE LightSpeed RT16 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT16 / LightSpeed Xtra) is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated acquisitions for all ages. These images may be obtained either with or without contrast. This device may include signal analysis and…
Read the full statement (232 words)
The GE LightSpeed RT16 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT16 / LightSpeed Xtra) is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated acquisitions for all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.
The GE LightSpeed RT16 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT16 / LightSpeed Xtra) is indicated for head, whole body, and vascular X-ray Computed Tomography applications.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
The system is capable of assisting with minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of Bariatrics patients, up to and including the morbidly obese population (BMI > 40).
When used in the LightSpeed RT18 configuration, the system can acquire 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/K082104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082104: GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed Xtra CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082104
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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