# K203518: Quicktome

- Pathway: 510(k) (Traditional)
- Applicant: Omniscient Neurotechnology Pty Ltd (O8t)
- Decided: Mar 9, 2021 after 98 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.
4 later devices descend from it; 2 cite it directly.
0 of 6 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
- K230913: ANDI (2023), 2 descendants of its own
- K252298: ANDI 2.0 (2025), 1 descendant of its own
- K261405: ANDI 2.2 (2026), 0 descendants of its own
- K243209: nordicMEDiVA (2024), 0 descendants of its own

## Indications for use
Quicktome is intended for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, planning, and 3D visualization (MPR reconstructions and 3D volume rendering). Modules are available for image processing and atlas-assisted visualization and segmentation, 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. Typical users of Quicktome are medical professionals, including but not limited to surgeons and radiologists.

Source page: https://510kreport.com/device/K203518
Methodology: https://510kreport.com/methodology