510(k) · Cleared
ClearedRevolution Ascend Sliding
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 22, 2024 as substantially equivalent to K213938 (Ge Healthcare Japan Corporation, 2022) after a 92-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Feb 22, 2024
- Review
- 92 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K013561 (2001). No later device cites it as a predicate yet.
- Root · 10 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 6 generations between
- 3 generations backK192686 Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd. · 2019 · Recalled
- 2 generations backK203169 Revolution AscendGe Healthcare Japan Corporation · 2020 · Recalled
- 1 generation backK213938 Revolution AscendGe Healthcare Japan Corporation · 2022 · Recalled
- This deviceK233749 Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 9 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 8 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 7 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 6 generations backK082761 GE Lightspeed 7.2 CT Scanner SystemGe Medical Systems, LLC · 2008 · Recalled
- 5 generations backK110227 Optima CT660Ge Medical Systems, LLC · 2011 · Recalled
- 4 generations backK131576 Optima CT660Ge Medical Systems, LLC · 2013 · Recalled
- 3 generations backK192686 Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd. · 2019 · Recalled
- 2 generations backK203169 Revolution AscendGe Healthcare Japan Corporation · 2020 · Recalled
- 1 generation backK213938 Revolution AscendGe Healthcare Japan Corporation · 2022 · Recalled
- This deviceK233749 Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −9 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −8 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −7 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| −6 | K082761 | GE Lightspeed 7.2 CT Scanner System | Ge Medical Systems, LLC | 2008 | 3 |
| −5 | K110227 | Optima CT660 | Ge Medical Systems, LLC | 2011 | 5 |
| −4 | K131576 | Optima CT660 | Ge Medical Systems, LLC | 2013 | 8 |
| −3 | K192686 | Revolution Maxima, Revolution Ace | Ge Hangwei Medical Systems Co., Ltd. | 2019 | 5 |
| −2 | K203169 | Revolution Ascend | Ge Healthcare Japan Corporation | 2020 | 1 |
| −1 | K213938 | Revolution Ascend | Ge Healthcare Japan Corporation | 2022 | 2 |
| 0 (this device) | K233749 | Revolution Ascend Sliding | Ge Hangwei Medical Systems Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K213938 | Revolution AscendSummary page 4…Predicate Device Information Device Name: Revolution Ascend Manufacturer: GE Healthcare Japan Corporation 510(k) Number: K213938, Cleared on February 4, 2022 Device Classification: Class II Page 1 ==… | 2022 |
| † | K091673 | GE Lightspeed Act FP16 | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 10 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K213938.
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. 2024, 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 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, including Axial, Cine, Helical (Volumetric), 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…
Read the full statement (136 words)
The 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, including Axial, Cine, Helical (Volumetric), 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 image can be post processed to produce additional imaging planes or analysis results.
The system is indicated for head, whole body, cardiac 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233749: Revolution Ascend Sliding.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233749
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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