# K191777: Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Jul 26, 2019 after 24 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K013561 (2001). 8 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163213: Revolution CT, Ge Medical Systems, LLC (2016) Summary page 6.

## Most influential descendants
- 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 (2021), 4 descendants of its own
- K253560: Enhanced Boundary for PCCT (2026), 0 descendants of its own
- K253520: Photonova Spectra, Photonova Spectra Select (2026), 0 descendants of its own
- K250941: Revolution Vibe (2025), 0 descendants of its own
- K233750: ECG-less Cardiac (2024), 0 descendants of its own

## Recalls of this device
- Mar 26, 2026 · Class II · Z-2150-2026: 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 A
- Mar 26, 2026 · Class II · Z-2153-2026: 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 A
- Mar 26, 2026 · Class II · Z-2154-2026: 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 A
- Mar 26, 2026 · Class II · Z-2152-2026: 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 A
- Feb 18, 2025 · Class II · Z-1303-2025: 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 flu
- Feb 18, 2025 · Class II · Z-1300-2025: 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 flu
- Feb 18, 2025 · Class II · Z-1297-2025: 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 flu
- Jun 30, 2021 · Class II · Z-0242-2022: 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 
- Jun 30, 2021 · Class II · Z-0815-2022: 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: 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: 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 acq
- Jun 30, 2021 · Class II · Z-2022-2021: 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 acq
- Mar 19, 2021 · Class II · Z-2004-2021: 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
- Dec 17, 2020 · Class II · Z-1129-2021: 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
- Dec 17, 2020 · Class II · Z-1130-2021: 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
- Nov 23, 2020 · Class II · Z-0694-2021: A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
- Nov 23, 2020 · Class II · Z-0695-2021: A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
- Sep 21, 2020 · Class II · Z-0306-2021: There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

## Indications for use
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 nonuric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

Source page: https://510kreport.com/device/K191777
Methodology: https://510kreport.com/methodology