# K223311: Philips CT 3500

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Dec 22, 2022 after 55 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: 8 generations back to K930090 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212441: Philips Incisive CT, Philips Healthcare (Suzhou) Co., Ltd. (2022) Summary page 5.
- K211168: Philips Incisive CT on Trailer, Philips Healthcare (Suzhou) Co., Ltd. (2021) Summary page 5.

## Indications for use
The Philips CT 3500 is a Computed Tomography X-Ray System intended to produce images of the head and 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 Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) and vascular X-ray Computed Tomography applications in patients of all ages. These 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/K223311
Methodology: https://510kreport.com/methodology