# K233767: OmniTom Elite

- Pathway: 510(k) (Traditional)
- Applicant: Neurologica Corporation
- Decided: Jun 10, 2024 after 199 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: 7 generations back to K944131 (1995). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223447: OmniTom Elite, Neurologica Corporation, A Subsidiary of Samsung (2023) Summary page 4.

## Most influential descendants
- K261125: BodyTom 64 (NL4100); OmniTom Elite (NL5000) (2026), 0 descendants of its own
- K250928: OmniTom Elite with PCD (2025), 0 descendants of its own

## Indications for use
The OmniTom Elite computed tomography (CT) system is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 40cm aperture, primarily the 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. OmniTom Elite with photon counting detectors (PCD) configuration has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI). OmniTom Elite with PCD is supported for adult imaging of the head and neck.

Source page: https://510kreport.com/device/K233767
Methodology: https://510kreport.com/methodology