# K212875: Spectral CT on Rails

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: May 13, 2022 after 246 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 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.
- K181797: Philips CT Big Bore Sliding Gantry Configuration, Phillips Medical Systems (Cleveland), Inc. (2018) Summary page 4.

## Recalls of this device
- Mar 7, 2026 · Class II · Z-1825-2026: Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential whe
- Jan 7, 2026 · Class II · Z-1318-2026: 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 
- Feb 28, 2025 · Class II · Z-1324-2025: Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
- Dec 13, 2023 · Class II · Z-1054-2024: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
- Oct 9, 2023 · Class II · Z-0306-2024: When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
- Oct 9, 2023 · Class II · Z-0319-2024: This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle

## Indications for use
The Spectral CT on Rails 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 supports, component parts, and accessories. The Spectral CT on Rails 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. 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. ] Med 2011; 365:395-409) and subsequent literature, for further information.

Source page: https://510kreport.com/device/K212875
Methodology: https://510kreport.com/methodology