510(k) · Cleared
Recalled · Class II · 2024Discovery Model CT590 RT and Optima Model CT580 CT Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 19, 2011 as substantially equivalent to K082104 (Ge Medical Systems, Inc., 2008) after a 517-day review. Its family tree reaches back 4 generations to 2001. 11 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 19, 2011
- Review
- 517 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K013561 (2001). 11 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 3 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 2 generations backK060052 GE Lightspeed Xtra CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 1 generation backK082104 GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed…Ge Medical Systems, Inc. · 2008 · Recalled
- This deviceK093581 Discovery Model CT590 RT and Optima Model CT580 CT SystemsGe Medical Systems, LLC · 2011
- Descendant · cites it directly · 9 of its ownK133640 ASIR-VGe Medical Systems, LLC · 2014
- Descendant · 2 generations on · 8 of its ownK183202 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019
- Descendant · 3 generations on · 2 of its ownK213999 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022
- Descendant · 3 generations on · 1 of its ownK193170 Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019
- Descendant · 4 generations on · 0 of its ownK253686 True Definition DLGe Healthcare Japan Corporation · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K133640ASIR-VGe Medical Systems, LLC · 2014 · cites it directly9descendants
- K183202Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019 · 2 generations on8descendants
- K213999Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022 · 3 generations on2descendants
- K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019 · 3 generations on1descendant
- K253686True Definition DLGe Healthcare Japan Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −3 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −2 | K060052 | GE Lightspeed Xtra CT Scanner System | Ge Medical Systems, LLC | 2006 | 3 |
| −1 | K082104 | GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 /… | Ge Medical Systems, Inc. | 2008 | 1 |
| 0 (this device) | K093581 | Discovery Model CT590 RT and Optima Model CT580 CT Systems | Ge Medical Systems, LLC | 2011 | — |
| +1 | K133640 | ASIR-V | Ge Medical Systems, LLC | 2014 | — |
| +2 | K183202 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2019 | — |
| +3 | K213999 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2022 | — |
| +3 | K193170 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2019 | — |
| +4 | K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082104 | GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed…Summary page 1…ystem per 21CFR892.1750 Product Code: 90-JAK Predicate Device(s): GE LightSpeed RT 16 / Xtra CT System (K082 104) 5-2 Manufacturer(s):… | 2008 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2024 | Class II | Z-0613-2025 | Component design/selection | 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 with helical, cine, and cardiac (if… |
| Nov 5, 2024 | Class II | Z-0600-2025 | Component design/selection | 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 with helical, cine, and cardiac (if… |
| May 19, 2017 | Class II | Z-2184-2017 | Software design | 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 | Software design | 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 hazardous situation may occur during a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K133640 (Ge Medical Systems, LLC, 2014) has gone furthest, with 9 descendants of its own.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
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…
Read the full statement (223 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093581 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093581: Discovery Model CT590 RT and Optima Model CT580 CT Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093581
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026