510(k) · Cleared
Recalled · Class II · 2024Revolution Maxima, Revolution Ace
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 Oct 24, 2019 as substantially equivalent to K131576 (Ge Medical Systems, LLC, 2013) after a 28-day review. Its family tree reaches back 7 generations to 2001. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 24, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 7 generations to K013561 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 6 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 5 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 4 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 3 generations backK082761 GE Lightspeed 7.2 CT Scanner SystemGe Medical Systems, LLC · 2008 · Recalled
- 2 generations backK110227 Optima CT660Ge Medical Systems, LLC · 2011 · Recalled
- 1 generation backK131576 Optima CT660Ge Medical Systems, LLC · 2013 · Recalled
- This deviceK192686 Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd. · 2019
- Descendant · cites it directly · 3 of its ownK203169 Revolution AscendGe Healthcare Japan Corporation · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK213938 Revolution AscendGe Healthcare Japan Corporation · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK233698 True Enhance DLGe Healthcare Japan Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK233749 Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K203169Revolution AscendGe Healthcare Japan Corporation · 2020 · cites it directly3descendants
- K213938Revolution AscendGe Healthcare Japan Corporation · 2022 · 2 generations on2descendants
- K233698True Enhance DLGe Healthcare Japan Corporation · 2024 · 3 generations on0descendants
- K233749Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −6 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −5 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −4 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| −3 | K082761 | GE Lightspeed 7.2 CT Scanner System | Ge Medical Systems, LLC | 2008 | 3 |
| −2 | K110227 | Optima CT660 | Ge Medical Systems, LLC | 2011 | 5 |
| −1 | K131576 | Optima CT660 | Ge Medical Systems, LLC | 2013 | 8 |
| 0 (this device) | K192686 | Revolution Maxima, Revolution Ace | Ge Hangwei Medical Systems Co., Ltd. | 2019 | — |
| +1 | K203169 | Revolution Ascend | Ge Healthcare Japan Corporation | 2020 | 1 |
| +2 | K213938 | Revolution Ascend | Ge Healthcare Japan Corporation | 2022 | 2 |
| +3 | K233698 | True Enhance DL | Ge Healthcare Japan Corporation | 2024 | — |
| +3 | K233749 | Revolution Ascend Sliding | Ge Hangwei Medical Systems Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203169 | Revolution Ascend | 2020 | 3 |
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-0612-2025 | 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-0603-2025 | 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-0606-2025 | 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-0610-2025 | 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-0611-2025 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 7 ancestors have a recall of any class.
- Of its descendants, K203169 (Ge Healthcare Japan Corporation, 2020) has gone furthest, with 3 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. 2019, 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/K192686 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192686: Revolution Maxima, Revolution Ace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192686
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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