# K081105: GE Lightspeed CT750 HD (Lightspeed 8.0)

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: May 9, 2008 after 21 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K013561 (2001). 4 ancestors in all.
35 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061817: Lightspeed 7.1 CT Scanner System, Ge Medical Systems, LLC (2006) Summary page 2.

## Most influential descendants
- K120833: Discovery CT750 HD (2012), 28 descendants of its own
- K133705: Revolution CT (2014), 21 descendants of its own
- K163213: Revolution CT (2016), 15 descendants of its own
- K103489: GE Veo Reconstruction Option (2011), 10 descendants of its own
- K133640: ASIR-V (2014), 9 descendants of its own

## Recalls of this device
- Nov 5, 2024 · Class II · Z-0615-2025: 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
- Nov 5, 2024 · Class II · Z-0616-2025: 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
- Jul 25, 2011 · Class II · Z-1188-2013: 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 re
- Apr 5, 2011 · Class II · Z-1940-2013: 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 perfu
- Mar 25, 2011 · Class II · Z-1148-2014: 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 doe

## Indications for use
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.

Source page: https://510kreport.com/device/K081105
Methodology: https://510kreport.com/methodology