# K250941: Revolution Vibe

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Aug 1, 2025 after 126 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K013561 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Ge Medical Systems, LLC (2021) Summary page 6.

## 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 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. The CT system is indicated for low dose CT for lung cancer screening. The screening must be performed within the established inclusion criteria of programs/ protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information

Source page: https://510kreport.com/device/K250941
Methodology: https://510kreport.com/methodology