# K082761: GE Lightspeed 7.2 CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Oct 8, 2008 after 16 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (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.
7 later devices descend from it; 1 cites it directly.
0 of 12 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 1.
- K040372: Lightspeed 7.0 CT Scanner System, Ge Medical Systems, LLC (2004) Summary page 1.

## Most influential descendants
- K110227: Optima CT660 (2011), 6 descendants of its own
- K131576: Optima CT660 (2013), 5 descendants of its own
- K192686: Revolution Maxima, Revolution Ace (2019), 4 descendants of its own
- K203169: Revolution Ascend (2020), 3 descendants of its own
- K213938: Revolution Ascend (2022), 2 descendants of its own

## Recalls of this device
- May 19, 2017 · Class II · Z-2183-2017: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- Sep 3, 2010 · Not classified · Z-0369-2011: GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.
- Sep 3, 2010 · Not classified · Z-0368-2011: GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.

## Indications for use
The GE LightSpeed 7.2 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, and Gated acquisitions. 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 7.2 CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

Source page: https://510kreport.com/device/K082761
Methodology: https://510kreport.com/methodology