# K133674: Philips Iqon Spectral CT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Cleveland)
- Decided: Nov 21, 2014 after 357 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: 7 generations back to K930090 (1993). 12 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131773: Brilliance Ict, Philips Healthcare (Cleveland) (2013) Summary page 4.

## Most influential descendants
- K163711: IQon Spectral CT (2017), 7 descendants of its own
- 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
- K150665: Philips Spectral CT Applications (2015), 1 descendant of its own

## Recalls of this device
- Feb 8, 2018 · Class II · Z-1414-2018: Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- Jan 11, 2018 · Class II · Z-0841-2018: 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment;
- Nov 8, 2017 · Class II · Z-0333-2018: There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a 
- Dec 16, 2016 · Class II · Z-1006-2017: Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
- Nov 14, 2016 · Class II · Z-0705-2017: A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
- Oct 13, 2016 · Class III · Z-0598-2017: The product label does not include the correct current rating.

## Indications for use
The Philips 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.

Source page: https://510kreport.com/device/K133674
Methodology: https://510kreport.com/methodology