# K202526: OmniTom Elite

- Pathway: 510(k) (Traditional)
- Applicant: Neurologica Corporation, A Subsidiary of Samsung Electronics
- Decided: Dec 23, 2020 after 113 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944131 (1995). 8 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K171183: OmniTom, Neurologica Corporation (2017) Summary page 4.

## Most influential descendants
- K211711: OmniTom Elite (2022), 4 descendants of its own
- K223447: OmniTom Elite (2023), 3 descendants of its own
- K233767: OmniTom Elite (2024), 2 descendants of its own
- K261125: BodyTom 64 (NL4100); OmniTom Elite (NL5000) (2026), 0 descendants of its own
- K250928: OmniTom Elite with PCD (2025), 0 descendants of its own

## Recalls of this device
- Jun 6, 2023 · Class II · Z-2068-2023: 1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 devi

## Indications for use
The OmniTom Elite CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40cm 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/K202526
Methodology: https://510kreport.com/methodology