# K133705: Revolution CT

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Apr 11, 2014 after 129 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K013561 (2001). 6 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120833: Discovery CT750 HD, Ge Medical Systems, LLC (2012) Summary page 2.

## Most influential descendants
- K163213: Revolution CT (2016), 15 descendants of its own
- K183202: Deep Learning Image Reconstruction (2019), 8 descendants of its own
- K191777: Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition (2019), 5 descendants of its own
- 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
- K161066: SpotLight CT (2016), 4 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
- 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-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
- 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-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
- Jan 19, 2019 · Class II · Z-1951-2019: Additional low dose radiation exposure.
- Jul 12, 2018 · Class II · Z-0776-2019: 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 sy
- May 24, 2018 · Class II · Z-2582-2018: 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: 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
- Apr 20, 2016 · Class II · Z-1589-2016: 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,
- Oct 23, 2015 · Class II · Z-0401-2016: 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 a
- Dec 19, 2014 · Class II · Z-0985-2015: 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: A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.

## 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.

Source page: https://510kreport.com/device/K133705
Methodology: https://510kreport.com/methodology