510(k) · Cleared
Recalled · Class II · 2018Discovery CT 590 RT, Optima CT 580, Optima CT 580 RT, Optima CT 580 W
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 Jan 17, 2014 as substantially equivalent to K093581 (Ge Medical Systems, LLC, 2011) and 1 other predicate after a 168-day review. Its family tree reaches back 6 generations to 1995. It has been recalled 2 times.
- Decided
- Jan 17, 2014
- Review
- 168 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945512 (1995). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 5 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 4 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 3 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 2 generations backK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
- 1 generation backK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- This deviceK132410 Discovery CT 590 RT, Optima CT 580, Optima CT 580 RT, Optima CT 580 WGe Medical Systems, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −5 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −4 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −3 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −2 | K022919 | Smart Breath Respiratory Compensation Option | GE Medical Systems | 2002 | — |
| −1 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| 0 (this device) | K132410 | Discovery CT 590 RT, Optima CT 580, Optima CT 580 RT, Optima CT 580 W | Ge Medical Systems, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K093581 | Discovery Model CT590 RT and Optima Model CT580 CT SystemsSummary page 2…) Premarket Notification Submission for Discovery CT590 RT/Optima CT580 with Deviceless 4D Option Predicated GE Discovery CT 590 RT/ Optima CT580 (K093581) Device(s): GE Advantage 4D(K032915) Manufacturer(s): GE Hangwei Medical Systems Co., Ltd… | 2011 |
| * | K032915 | Advantage 4D OptionSummary page 2…/Optima CT580 with Deviceless 4D Option Predicated GE Discovery CT 590 RT/ Optima CT580 (K093581) Device(s): GE Advantage 4D(K032915) Manufacturer(s): GE Hangwei Medical Systems Co., Ltd No. 1 North Yong Chang No… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2018 | Class II | Z-2581-2018 | Component change control | 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 | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K093581.
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. 2014, 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/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…
Read the full statement (298 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132410: Discovery CT 590 RT, Optima CT 580, Optima CT 580 RT, Optima CT 580 W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132410
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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