# K132410: Discovery CT 590 RT, Optima CT 580, Optima CT 580 RT, Optima CT 580 W

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jan 17, 2014 after 168 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945512 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093581: Discovery Model CT590 RT and Optima Model CT580 CT Systems, Ge Medical Systems, LLC (2011) Summary page 2.
- K032915: Advantage 4D Option, Ge Medical Systems, LLC (2003) Summary page 2.

## Recalls of this device
- May 24, 2018 · Class II · Z-2581-2018: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- May 19, 2017 · Class II · Z-2184-2017: 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 Discovery CT590 RT/Optima CT580 Computed Tomography Systems are 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 (Respiratory and Cardiac) 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 Discovery CT590 RT/Optima CT580 Computed Tomography Systems are indicated for head, whole body, 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. 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). The system can acquire CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer. If the Deviceless 4D option is included on the system, the system can be used to efficiently provide and display CT images of all phases of a breathing cycle for the evaluation of respiration-induced motion of the chest for use with therapy planning and simulation. The software calculates the breathing period to determine the Cine acquisition duration and the cine time between images which is automatically imported to the 4D cine acquisition. The software then uses information derived from the images for the binning process.

Source page: https://510kreport.com/device/K132410
Methodology: https://510kreport.com/methodology