# K222359: Quicktome Software Suite

- Pathway: 510(k) (Traditional)
- Applicant: Omniscient Neurotechnology Pty Ltd (O8t)
- Decided: May 30, 2023 after 299 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K081512 (2008). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081512: Stealthviz Advanced Planning Application with Stealthdti Package, Medtronic Navigation, Inc. (2008) Summary page 4.

## Most influential descendants
- K251009: Cirrus Resting State fMRI Software (2025), 0 descendants of its own
- K241094: Bullsai (2024), 0 descendants of its own

## Indications for use
The Quicktome Software Suite is composed of a set of modules intended for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, planning, 3D visualization (MPR reconstructions and 3D volume rendering) and display of BOLD (blood oxygen level dependent) resting-state MRI scan studies. Modules are available for image processing, atlas-assisted visualization and segmentation, resting state analysis and visualization, and target export creation and selection, where an output can be generated for use by a system capable of reading DICOM image sets. Quicktome is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white-matter tracts based on constrained spherical deconvolution methods and for the use of said maps to select and create exports. Quicktome can generate motor, language, and vision resting state fMRI correlation maps using task-analogous seeds. Typical users of Quicktome are medical professionals, including but not limited to surgeons, clinicians, and radiologists.

Source page: https://510kreport.com/device/K222359
Methodology: https://510kreport.com/methodology