# K213938: Revolution Ascend

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Japan Corporation
- Decided: Feb 4, 2022 after 50 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K013561 (2001). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203169: Revolution Ascend, Ge Healthcare Japan Corporation (2020) Summary page 6.

## Most influential descendants
- K233698: True Enhance DL (2024), 0 descendants of its own
- K233749: Revolution Ascend Sliding (2024), 0 descendants of its own

## Recalls of this device
- Mar 26, 2026 · Class II · Z-2149-2026: 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
- Nov 5, 2024 · Class II · Z-0605-2025: GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly

## Indications for use
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. 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 in patients of all ages. 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/K213938
Methodology: https://510kreport.com/methodology