510(k) · Cleared
Recalled · Class II · 2024Optima CT520
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Hangwei Medical Systems Co., Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 8, 2013 as substantially equivalent to K082816 (Ge Medical Systems, LLC, 2008) after a 79-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Feb 8, 2013
- Review
- 79 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 4 generations to K013561 (2001). 6 ancestors in all, the oldest K000300 (2000). 1 later device descends from it, 1 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 backK052855 Starspeed Series CT Scanner SystemsGE Healthcare · 2005 · Recalled
- 1 generation backK082816 GE Brightspeed Delight CT Scanner SystemGe Medical Systems, LLC · 2008 · Recalled
- This deviceK123596 Optima CT520Ge Hangwei Medical Systems Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK171013 Revolution ACTGe Hangwei Medical Systems Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K171013Revolution ACTGe Hangwei Medical Systems Co., Ltd. · 2017 · cites it directly0descendants
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 | K052855 | Starspeed Series CT Scanner Systems | GE Healthcare | 2005 | 5 |
| −1 | K082816 | GE Brightspeed Delight CT Scanner System | Ge Medical Systems, LLC | 2008 | 9 |
| 0 (this device) | K123596 | Optima CT520 | Ge Hangwei Medical Systems Co., Ltd. | 2013 | — |
| +1 | K171013 | Revolution ACT | Ge Hangwei Medical Systems Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K082816 | GE Brightspeed Delight CT Scanner SystemSummary page 1…Computed Tomography X-ray System 2 1CFR892.1750 Product Code: JAK Predicated Device(s): GE BrightSpeed Elite Select (K0828 16) Marketed Devices: The Optima CT520 is of comparable type and substantially equivalent to GE Healthcare's currently marketed… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171013 | Revolution ACT | 2017 | 0 |
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-0601-2025 | 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-0604-2025 | 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 24, 2018 | Class II | Z-2585-2018 | 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-2185-2017 | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
| Oct 9, 2013 | Class II | Z-0840-2014 | Software design | There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer. This is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K171013 (Ge Hangwei Medical Systems Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082816.
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. 2013, 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 GE Optima CT520 Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient, and equipment supports, components…
Read the full statement (145 words)
The GE Optima CT520 Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. 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 Optima CT520 CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123596 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123596: Optima CT520.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123596
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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