# K093581: Discovery Model CT590 RT and Optima Model CT580 CT Systems

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Apr 19, 2011 after 517 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 4 (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.
11 later devices descend from it; 2 cite 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)
- K082104: GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed Xtra CT System, Ge Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K253686: True Definition DL (2026), 0 descendants of its own

## Recalls of this device
- Nov 5, 2024 · Class II · Z-0613-2025: 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-0600-2025: 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
- 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.
- Feb 14, 2014 · Class II · Z-1245-2014: GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential 

## Indications for use
The Discovery CT590 RT and Optima CT5BO series of Computed Tomography systems are intended to produce ctross-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 in patients of all ages. These images may be obtained either with or without contrast. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. These devices 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 and Optima CT580 series of Computed Tomography systems are intended 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 systems are 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 systems can acquire CT anatomical images that are clinically useful inthe simulation and planning of radiation therapy for the treatment of cancer.

Source page: https://510kreport.com/device/K093581
Methodology: https://510kreport.com/methodology