# K153444: Philips Multislice CT System with Low Dose CT Lung Cancer

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Apr 8, 2016 after 133 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930090 (1993). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033326: Philips Plus Computed Tomography System, Philips Medical Systems, Inc. (2003) Summary page 4.

## Most influential descendants
- K180901: Low Dose CT Lung Cancer Screening Option (2018), 0 descendants of its own

## Indications for use
The Philips Multislice CT Systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The scanners are intended to be used for diagnostic imaging and 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/K153444
Methodology: https://510kreport.com/methodology