# K193454: IQon Spectral CT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jan 24, 2020 after 42 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: 9 generations back to K930090 (1993). 14 ancestors in all.
6 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)
- K163711: IQon Spectral CT, Philips Medical Systems (Cleveland), Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K244008: Spectral CT (2025), 0 descendants of its own

## Recalls of this device
- Aug 7, 2026 · Class II · Z-3041-2026: Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
- Jun 11, 2026 · Class II · Z-2651-2026: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acqui
- Jan 7, 2026 · Class II · Z-1316-2026: 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 
- Jun 8, 2021 · Class II · Z-2317-2021: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recomme
- May 1, 2021 · Class II · Z-1985-2021: Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the
- Apr 6, 2020 · Class II · Z-1923-2020: The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

## 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 analyse 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 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 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/K193454
Methodology: https://510kreport.com/methodology