# K150665: Philips Spectral CT Applications

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nethrlands BV
- Decided: Aug 7, 2015 after 144 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (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.
1 later device descends from it; 1 cites it directly.
0 of 15 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 4.

## Most influential descendants
- K260169: AV Cardiac CT (2026), 0 descendants of its own

## Recalls of this device
- Nov 14, 2016 · Class II · Z-0706-2017: A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images

## Indications for use
The Philips Spectral CT Applications support viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide 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 Spectral enhanced Advanced Vessel Analysis (sAVA) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels. The Spectral enhanced Comprehensive Cardiac Analysis (sCCA) application is intended to assist clinicians in viewing and evaluating cardiovascular CT images. The Spectral enhanced Tumor Tracking (sTT) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of tumors.

Source page: https://510kreport.com/device/K150665
Methodology: https://510kreport.com/methodology