510(k) · Cleared
Recalled · Class II · 2024GE Lightspeed CT750 HD (Lightspeed 8.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · JAK System, X-Ray, Tomography, Computed
Cleared on May 9, 2008 as substantially equivalent to K061817 (Ge Medical Systems, LLC, 2006) after a 21-day review. Its family tree reaches back 4 generations to 2001. 35 later devices descend from it. It has been recalled 5 times.
- Decided
- May 9, 2008
- Review
- 21 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 4 generations to K013561 (2001). 35 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 3 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 2 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 1 generation backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- This deviceK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008
- Descendant · cites it directly · 28 of its ownK120833 Discovery CT750 HDGe Medical Systems, LLC · 2012 · Recalled
- Descendant · 2 generations on · 21 of its ownK133705 Revolution CTGe Medical Systems, LLC · 2014 · Recalled
- Descendant · 3 generations on · 15 of its ownK163213 Revolution CTGe Medical Systems, LLC · 2016 · Recalled
- Descendant · cites it directly · 10 of its ownK103489 GE Veo Reconstruction OptionGeneral Electric Co. · 2011
- Descendant · 2 generations on · 9 of its ownK133640 ASIR-VGe Medical Systems, LLC · 2014
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K120833Discovery CT750 HDGe Medical Systems, LLC · 2012 · cites it directly28descendants
- K133705Revolution CTGe Medical Systems, LLC · 2014 · 2 generations on21descendants
- K163213Revolution CTGe Medical Systems, LLC · 2016 · 3 generations on15descendants
- K103489GE Veo Reconstruction OptionGeneral Electric Co. · 2011 · cites it directly10descendants
- K133640ASIR-VGe Medical Systems, LLC · 2014 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −3 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −2 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −1 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| 0 (this device) | K081105 | GE Lightspeed CT750 HD (Lightspeed 8.0) | GE Healthcare | 2008 | — |
| +1 | K120833 | Discovery CT750 HD | Ge Medical Systems, LLC | 2012 | 1 |
| +2 | K133705 | Revolution CT | Ge Medical Systems, LLC | 2014 | 14 |
| +3 | K163213 | Revolution CT | Ge Medical Systems, LLC | 2016 | 16 |
| +1 | K103489 | GE Veo Reconstruction Option | General Electric Co. | 2011 | — |
| +2 | K133640 | ASIR-V | Ge Medical Systems, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 3 | 0 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K061817 | Lightspeed 7.1 CT Scanner SystemSummary page 2…5-2 Predicate Device(s): GE LightSpeed 7.1 CT Scanner System (K061817) DEVICE DESCRIPTION The GE LightSpeed CT750 HD CT Scanner System (aka LightSpeed 8.0) is composed of a gantry, patient table, o… | 2006 |
What descends from it? (35)
See all 353 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2024 | Class II | Z-0615-2025 | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if… |
| Nov 5, 2024 | Class II | Z-0616-2025 | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if… |
| Jul 25, 2011 | Class II | Z-1188-2013 | Process control | Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking… |
| Apr 5, 2011 | Class II | Z-1940-2013 | Software design | GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical… |
| Mar 25, 2011 | Class II | Z-1148-2014 | Software design | When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image… |
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 1.8 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K120833 (Ge Medical Systems, LLC, 2012) has gone furthest, with 28 descendants of its own.
- 2 other devices also cite its predicate K061817.
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 CT750 HD Computed Tomography X-ray system 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), Cardiac, Spectral, 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…
Read the full statement (231 words)
The GE LightSpeed CT750 HD Computed Tomography X-ray system 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), Cardiac, Spectral, 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 CT750 HD CT Scanner System is indicated for head, whole body, cardiac 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.
If the spectral imaging option is included on the system, the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081105 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081105: GE Lightspeed CT750 HD (Lightspeed 8.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081105
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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