# K253450: BodyTom Elite (NL4000)

- Pathway: 510(k) (Traditional)
- Applicant: NeuroLogica Corp., a Samsung Company
- Decided: Jul 28, 2026 after 299 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: 9 generations back to K944131 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170238: BodyTom Elite, Neurologica Corporation, A Subsidiary of Samsung Electronics (2017) Summary page 5.

## Indications for use
The BodyTom Elite system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture. The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast. BodyTom Elite system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies. *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/K253450
Methodology: https://510kreport.com/methodology