# K120833: Discovery CT750 HD

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Jun 12, 2012 after 85 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K013561 (2001). 5 ancestors in all.
28 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081105: GE Lightspeed CT750 HD (Lightspeed 8.0), GE Healthcare (2008) Summary page 2.

## Most influential descendants
- K133705: Revolution CT (2014), 21 descendants of its own
- 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

## Recalls of this device
- Nov 5, 2024 · Class II · Z-0609-2025: 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 Computed Tomography X-ray 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, Spectral, and Gated acquisitions for 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 for both single kV acquisitions and with the fast IkV switching spectral imaging option (GSI). 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.

Source page: https://510kreport.com/device/K120833
Methodology: https://510kreport.com/methodology