# K261795: Quicktome Software Suite

- Pathway: 510(k) (Traditional)
- Applicant: Omniscient Neurotechnology Pty, Ltd.
- Decided: Sep 10, 2026 after 104 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 8 generations back to K050438 (2005). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241083: SIS System, Surgical Information Sciences, Inc. (2024) Summary page 5.

## Indications for use
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, image fusion, 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, automated and manual segmentation object creation, detection, and adjustment, 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. Quicktome can be used in conjunction with other clinical methods as an aid in visualization of deep brain structures, such as the subthalamic nuclei (STN), globus pallidus interna (GPi) and ventralis intermediate nucleus (VIM). Typical users of Quicktome are medical professionals, including but not limited to surgeons, clinicians, and radiologists.

Source page: https://510kreport.com/device/K261795
Methodology: https://510kreport.com/methodology