# K250928: OmniTom Elite with PCD

- Pathway: 510(k) (Traditional)
- Applicant: Neurologica Corporation
- Decided: Sep 8, 2025 after 164 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 K944131 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233767: OmniTom Elite, Neurologica Corporation (2024) Summary page 5.

## Indications for use
The OmniTom Elite with PCD computed tomography (CT) system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, 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. The PCD CT system has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI).

Source page: https://510kreport.com/device/K250928
Methodology: https://510kreport.com/methodology