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 Dec 16, 2016 as substantially equivalent to K133705 (Ge Medical Systems, LLC, 2014) after a 30-day review. Its family tree reaches back 7 generations to 2001. 15 later devices descend from it. It has been recalled 16 times.
- Decided
- Dec 16, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 16
- Predicates
- 1
Its longest line of descent runs back 7 generations to K013561 (2001). 15 later devices descend from it, 2 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 backK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · Recalled
- 2 generations backK120833 Discovery CT750 HDGe Medical Systems, LLC · 2012 · Recalled
- 1 generation backK133705 Revolution CTGe Medical Systems, LLC · 2014 · Recalled
- This deviceK163213 Revolution CTGe Medical Systems, LLC · 2016
- Descendant · cites it directly · 8 of its ownK183202 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019
- Descendant · cites it directly · 5 of its ownK191777 Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with…Ge Medical Systems, LLC · 2019 · Recalled
- Descendant · 2 generations on · 4 of its ownK213715 Revolution Apex, Revolution Apex Elite, Revolution Apex Plus…Ge Medical Systems, LLC · 2021 · Recalled
- Descendant · 2 generations on · 2 of its ownK213999 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK193170 Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K183202Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019 · cites it directly8descendants
- K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionGe Medical Systems, LLC · 2019 · cites it directly5descendants
- K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex…Ge Medical Systems, LLC · 2021 · 2 generations on4descendants
- K213999Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022 · 2 generations on2descendants
- K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019 · 2 generations on1descendant
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 | K081105 | GE Lightspeed CT750 HD (Lightspeed 8.0) | GE Healthcare | 2008 | 5 |
| −2 | K120833 | Discovery CT750 HD | Ge Medical Systems, LLC | 2012 | 1 |
| −1 | K133705 | Revolution CT | Ge Medical Systems, LLC | 2014 | 14 |
| 0 (this device) | K163213 | Revolution CT | Ge Medical Systems, LLC | 2016 | — |
| +1 | K183202 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2019 | — |
| +1 | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex… | Ge Medical Systems, LLC | 2019 | 18 |
| +2 | K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex… | Ge Medical Systems, LLC | 2021 | 11 |
| +2 | K213999 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2022 | — |
| +2 | K193170 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K133705 | Revolution CTSummary page 6…et Notification Submission- Revolution CT Marketed Devices: Revolution CT with GSI option is a CT device with modifications made to the predicate device Revolution CT (K133705) to enable Gemstone Spectral Imaging (GSI) option. It is of comparable type and substantially equivalent to its predicate device… | 2014 |
| † | K081105 | GE Lightspeed CT750 HD (Lightspeed 8.0) | 2008 |
| † | K120833 | Discovery CT750 HD | 2012 |
What descends from it? (15)
See all 152 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… |
| Mar 26, 2026 | Class II | Z-2153-2026 | 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… |
| Mar 26, 2026 | Class II | Z-2154-2026 | 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… |
| Feb 18, 2025 | Class II | Z-1303-2025 | Process change control | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor… |
| Feb 18, 2025 | Class II | Z-1297-2025 | Process change control | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor… |
| 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-0815-2022 | 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-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. |
| Jun 30, 2021 | Class II | Z-2022-2021 | 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-1129-2021 | 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… |
| 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). |
The 5 latest of 16 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 15 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 7 ancestors have a recall of any class.
- Of its descendants, K183202 (Ge Medical Systems, LLC, 2019) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K133705.
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. 2016, 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 (316 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.
If the spectral imaging option is included on the system, the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.
GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163213 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163213: Revolution CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163213
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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