# K244008: Spectral CT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Technologies, Ltd.
- Decided: May 16, 2025 after 141 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K930090 (1993). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203020: Spectral CT, Philips Medical Systems Nederland B.V. (2021) Summary page 4.
- K240844: Spectral CT 7500 RT, Philips Medical Systems Technologies, Ltd. (2024) Summary page 5.

## Recalls of this device
- Aug 21, 2026 · Class II · Z-0078-2027: Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
- Aug 18, 2026 · Class II · Z-3155-2026: The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving
- Jan 7, 2026 · Class II · Z-1317-2026: As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If 

## Indications for use
The Spectral CT system is a Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment support, component parts, and accessories. The Spectral CT system acquires one CT dataset – composed of data from a higher-energy detected X-ray spectrum and a lower- energy detected X-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment preparation and radiation therapy planning/simulation usage only. This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. 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/K244008
Methodology: https://510kreport.com/methodology