510(k) · Cleared
Recalled · Class II · 2026Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition
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 17, 2021 as substantially equivalent to K191777 (Ge Medical Systems, LLC, 2019) after a 23-day review. Its family tree reaches back 9 generations to 2001. 4 later devices descend from it. It has been recalled 11 times.
- Decided
- Dec 17, 2021
- Review
- 23 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 9 generations to K013561 (2001). 4 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 5 generations between
- 3 generations backK133705 Revolution CTGe Medical Systems, LLC · 2014 · Recalled
- 2 generations backK163213 Revolution CTGe Medical Systems, LLC · 2016 · Recalled
- 1 generation backK191777 Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with…Ge Medical Systems, LLC · 2019 · Recalled
- This deviceK213715 Revolution Apex, Revolution Apex Elite, Revolution Apex Plus…Ge Medical Systems, LLC · 2021
- Descendant · cites it directly · 0 of its ownK253560 Enhanced Boundary for PCCTGe Medical Systems, LLC · 2026
- Descendant · cites it directly · 0 of its ownK253520 Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC · 2026
- Descendant · cites it directly · 0 of its ownK250941 Revolution VibeGe Medical Systems, LLC · 2025
- Descendant · cites it directly · 0 of its ownK233750 ECG-less CardiacGe Medical Systems, LLC · 2024
Show all 9 generations
- Root · 9 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 8 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 7 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 6 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 5 generations backK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · Recalled
- 4 generations backK120833 Discovery CT750 HDGe Medical Systems, LLC · 2012 · Recalled
- 3 generations backK133705 Revolution CTGe Medical Systems, LLC · 2014 · Recalled
- 2 generations backK163213 Revolution CTGe Medical Systems, LLC · 2016 · Recalled
- 1 generation backK191777 Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with…Ge Medical Systems, LLC · 2019 · Recalled
- This deviceK213715 Revolution Apex, Revolution Apex Elite, Revolution Apex Plus…Ge Medical Systems, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K253560Enhanced Boundary for PCCTGe Medical Systems, LLC · 2026 · cites it directly0descendants
- K253520Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC · 2026 · cites it directly0descendants
- K250941Revolution VibeGe Medical Systems, LLC · 2025 · cites it directly0descendants
- K233750ECG-less CardiacGe Medical Systems, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −8 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −7 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −6 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| −5 | K081105 | GE Lightspeed CT750 HD (Lightspeed 8.0) | GE Healthcare | 2008 | 5 |
| −4 | K120833 | Discovery CT750 HD | Ge Medical Systems, LLC | 2012 | 1 |
| −3 | K133705 | Revolution CT | Ge Medical Systems, LLC | 2014 | 14 |
| −2 | K163213 | Revolution CT | Ge Medical Systems, LLC | 2016 | 16 |
| −1 | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex… | Ge Medical Systems, LLC | 2019 | 18 |
| 0 (this device) | K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex… | Ge Medical Systems, LLC | 2021 | — |
| +1 | K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | 2026 | — |
| +1 | K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | 2026 | — |
| +1 | K250941 | Revolution Vibe | Ge Medical Systems, LLC | 2025 | — |
| +1 | K233750 | ECG-less Cardiac | Ge Medical Systems, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionSummary page 5…GE Medical System, LLC. 3000 North Grandview Blvd Waukesha, WI 53188 510(k) number K191777 cleared on July 26, 2019 Regulation number 21 CFR 892.1750 Computed tomography x-ray system / /product Code… | 2019 |
| † | K183161 | SnapShot Freeze 2 | 2019 |
What descends from it? (4)
4 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-2151-2026 | 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-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-2155-2026 | 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… |
| Mar 26, 2026 | Class II | Z-2152-2026 | 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-1298-2025 | 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-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-1300-2025 | 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-1301-2025 | 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… |
The 5 latest of 11 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 20 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 9 of the 9 ancestors have a recall of any class.
- Of its descendants, K253560 (Ge Medical Systems, LLC, 2026) has gone furthest, with 0 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. 2021, 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 systems with 160 mm detector coverage have 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…
Read the full statement (321 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 systems with 160 mm detector coverage have 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 nonuric 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/K213715 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213715: Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213715
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