510(k) · Cleared
Recalled · Class II · 2026Revolution CT
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 Apr 11, 2014 as substantially equivalent to K120833 (Ge Medical Systems, LLC, 2012) after a 129-day review. Its family tree reaches back 6 generations to 2001. 21 later devices descend from it. It has been recalled 14 times.
- Decided
- Apr 11, 2014
- Review
- 129 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 14
- Predicates
- 1
Its longest line of descent runs back 6 generations to K013561 (2001). 21 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 5 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 4 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 3 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 2 generations backK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · Recalled
- 1 generation backK120833 Discovery CT750 HDGe Medical Systems, LLC · 2012 · Recalled
- This deviceK133705 Revolution CTGe Medical Systems, LLC · 2014
- Descendant · cites it directly · 15 of its ownK163213 Revolution CTGe Medical Systems, LLC · 2016 · Recalled
- Descendant · 2 generations on · 8 of its ownK183202 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019
- Descendant · 2 generations on · 5 of its ownK191777 Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with…Ge Medical Systems, LLC · 2019 · Recalled
- Descendant · 3 generations on · 4 of its ownK213715 Revolution Apex, Revolution Apex Elite, Revolution Apex Plus…Ge Medical Systems, LLC · 2021 · Recalled
- Descendant · cites it directly · 4 of its ownK161066 SpotLight CTArineta, Ltd. · 2016
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K163213Revolution CTGe Medical Systems, LLC · 2016 · cites it directly15descendants
- K183202Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019 · 2 generations on8descendants
- K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionGe Medical Systems, LLC · 2019 · 2 generations on5descendants
- K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex…Ge Medical Systems, LLC · 2021 · 3 generations on4descendants
- K161066SpotLight CTArineta, Ltd. · 2016 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −5 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −4 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −3 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| −2 | K081105 | GE Lightspeed CT750 HD (Lightspeed 8.0) | GE Healthcare | 2008 | 5 |
| −1 | K120833 | Discovery CT750 HD | Ge Medical Systems, LLC | 2012 | 1 |
| 0 (this device) | K133705 | Revolution CT | Ge Medical Systems, LLC | 2014 | — |
| +1 | K163213 | Revolution CT | Ge Medical Systems, LLC | 2016 | 16 |
| +2 | K183202 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2019 | — |
| +2 | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex… | Ge Medical Systems, LLC | 2019 | 18 |
| +3 | K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex… | Ge Medical Systems, LLC | 2021 | 11 |
| +1 | K161066 | SpotLight CT | Arineta, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K120833 | Discovery CT750 HDSummary page 2…ation Submission- Revolution CT Marketed Devices: The Revolution CT is a new CT device built upon the existing technologies of the predicate device Discovery CT75O HD (K120833). It is of comparable type and substantially equivalent to its predicate device Discovery CT750 HID and GE's other currently mark… | 2012 |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2026 | Class II | Z-2150-2026 | Software design | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution… |
| Jun 30, 2021 | Class II | Z-0242-2022 | Radiation Control for Health and Safety Act | The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will… |
| Jun 30, 2021 | Class II | Z-0816-2022 | Radiation Control for Health and Safety Act | The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high. |
| Jun 30, 2021 | Class II | Z-2021-2021 | 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. |
| Mar 19, 2021 | Class II | Z-2004-2021 | Radiation Control for Health and Safety Act | GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or… |
| Dec 17, 2020 | Class II | Z-1130-2021 | Process change control | GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table… |
| Jan 19, 2019 | Class II | Z-1951-2019 | Device Design | Additional low dose radiation exposure. |
| Jul 12, 2018 | Class II | Z-0776-2019 | Software design | On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is… |
| May 24, 2018 | Class II | Z-2582-2018 | 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 9, 2016 | Class II | Z-1915-2016 | Process control | GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user.… |
| Apr 20, 2016 | Class II | Z-1589-2016 | Process control | An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a… |
| Oct 23, 2015 | Class II | Z-0401-2016 | Software design | GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology… |
| Dec 19, 2014 | Class II | Z-0985-2015 | Process control | Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported. |
| Nov 12, 2014 | Class II | Z-0955-2015 | Radiation Control for Health and Safety Act | A required quality control test was not performed during installation associated with the software of the Revolution CT scanner. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 6 ancestors have a recall of any class.
- Of its descendants, K163213 (Ge Medical Systems, LLC, 2016) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K120833.
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 system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc.. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients…
Read the full statement (173 words)
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc.. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of 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 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/K133705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133705: Revolution CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133705
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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