# K163711: IQon Spectral CT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Apr 5, 2017 after 96 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: 8 generations back to K930090 (1993). 13 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133674: Philips Iqon Spectral CT, Philips Healthcare (Cleveland) (2014) Summary page 5.

## Most influential descendants
- K193454: IQon Spectral CT (2020), 6 descendants of its own
- K203020: Spectral CT (2021), 5 descendants of its own
- K240844: Spectral CT 7500 RT (2024), 3 descendants of its own
- K253649: Spectral CT Verida Family (2026), 0 descendants of its own
- K252992: CT Rembra RT; CT Areta RT; CT Rembra (2026), 0 descendants of its own

## Recalls of this device
- Aug 13, 2025 · Class II · Z-2601-2025: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Jun 24, 2019 · Class II · Z-2192-2019: In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been 

## Indications for use
The IQon Spectral CT 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 IQon 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. 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/K163711
Methodology: https://510kreport.com/methodology