# K060052: GE Lightspeed Xtra CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Apr 19, 2006 after 103 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: 2 generations back to K013561 (2001). 2 ancestors in all.
13 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)
- K030420: Lightspeed 5.0 Computed Tomography System, GE Medical Systems (2003) Summary page 1.

## Most influential descendants
- K082104: GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed Xtra CT System (2008), 12 descendants of its own
- 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

## 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.
- Dec 21, 2006 · Not classified · Z-0805-2007: Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
- Dec 8, 2006 · Not classified · Z-0506-2007: When the manual cradle release feature on the table is used to move a patient out of the gantry, a discrepancy of up to 6mm between the numerical display on the gantry and the actual position of the t

## Indications for use
The GE LightSpeed Xtra CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of obese patients, up to and including the morbidly obese population (BMI > 40). When used in the LightSpeed RT Pro 16 configuration: The system acquires 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/K060052
Methodology: https://510kreport.com/methodology