# K082104: GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed Xtra CT System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Sep 2, 2008 after 39 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K013561 (2001). 3 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060052: GE Lightspeed Xtra CT Scanner System, Ge Medical Systems, LLC (2006) Summary page 2.

## Most influential descendants
- K093581: Discovery Model CT590 RT and Optima Model CT580 CT Systems (2011), 11 descendants of its own
- K133640: ASIR-V (2014), 9 descendants of its own
- K183202: Deep Learning Image Reconstruction (2019), 8 descendants of its own
- K213999: Deep Learning Image Reconstruction (2022), 2 descendants of its own
- K193170: Deep Learning Image Reconstruction (2019), 1 descendant of its own

## Recalls of this device
- May 19, 2017 · Class II · Z-2189-2017: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

## Indications for use
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.

Source page: https://510kreport.com/device/K082104
Methodology: https://510kreport.com/methodology