510(k) · Cleared
Recalled · Class II · 2021Revolution Ascend
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Japan Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 20, 2020 as substantially equivalent to K192686 (Ge Hangwei Medical Systems Co., Ltd., 2019) after a 28-day review. Its family tree reaches back 8 generations to 2001. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 20, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K013561 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 7 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 6 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 5 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 4 generations backK082761 GE Lightspeed 7.2 CT Scanner SystemGe Medical Systems, LLC · 2008 · Recalled
- 3 generations backK110227 Optima CT660Ge Medical Systems, LLC · 2011 · Recalled
- 2 generations backK131576 Optima CT660Ge Medical Systems, LLC · 2013 · Recalled
- 1 generation backK192686 Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd. · 2019 · Recalled
- This deviceK203169 Revolution AscendGe Healthcare Japan Corporation · 2020
- Descendant · cites it directly · 2 of its ownK213938 Revolution AscendGe Healthcare Japan Corporation · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK233698 True Enhance DLGe Healthcare Japan Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK233749 Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −7 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −6 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −5 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| −4 | K082761 | GE Lightspeed 7.2 CT Scanner System | Ge Medical Systems, LLC | 2008 | 3 |
| −3 | K110227 | Optima CT660 | Ge Medical Systems, LLC | 2011 | 5 |
| −2 | K131576 | Optima CT660 | Ge Medical Systems, LLC | 2013 | 8 |
| −1 | K192686 | Revolution Maxima, Revolution Ace | Ge Hangwei Medical Systems Co., Ltd. | 2019 | 5 |
| 0 (this device) | K203169 | Revolution Ascend | Ge Healthcare Japan Corporation | 2020 | — |
| +1 | K213938 | Revolution Ascend | Ge Healthcare Japan Corporation | 2022 | 2 |
| +2 | K233698 | True Enhance DL | Ge Healthcare Japan Corporation | 2024 | — |
| +2 | K233749 | Revolution Ascend Sliding | Ge Hangwei Medical Systems Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K192686 | Revolution Maxima, Revolution AceSummary page 5…Hino-shi, Tokyo, 191-8503, Japan Predicate Device Information: Device Name Revolution Maxima 510 (K) number K192686 cleared on October, 2019 Regualation Number/ Computed Tomography X-ray System, 21 CFR 892.1750 / Classification… | 2019 |
| † | K153429 | SmartView 3D Option | 2016 |
| † | K171013 | Revolution ACT | 2017 |
| † | K133705 | Revolution CT | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213938 | Revolution Ascend | 2022 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2021 | Class II | Z-2023-2021 | Process design | When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition. |
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.
- 8 of the 8 ancestors have a recall of any class.
- Of its descendants, K213938 (Ge Healthcare Japan Corporation, 2022) has gone furthest, with 2 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. 2020, 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 images 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/K203169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203169: Revolution Ascend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203169
Report an extraction error
Are you the manufacturer?
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