# K172539: CereTom Elite

- Pathway: 510(k) (Traditional)
- Applicant: Neurologica Corporation, A Subsidiary of Samsung Electronics
- Decided: Nov 22, 2017 after 91 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: 3 generations back to K944131 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051765: Ceretom, Model NL3000, Neurologica Corporation (2005) Summary page 4.

## Indications for use
The NL3000 [CereTom Elite] CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 25cm field of view, primarily head and neck. 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.

Source page: https://510kreport.com/device/K172539
Methodology: https://510kreport.com/methodology