# K241094: Bullsai

- Pathway: 510(k) (Traditional)
- Applicant: Turing Medical Technologies, Inc.
- Decided: Aug 13, 2024 after 113 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: 2 generations back to K081512 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222359: Quicktome Software Suite, Omniscient Neurotechnology Pty Ltd (O8t) (2023) Summary page 4.

## Indications for use
Bullsai is composed of a set of modules intended for analysis and processing of medical images and other healthcare data. It includes functions for image manipulation, basic measurements, and planning. Bullsai is indicated for use in image processing, registration, atlas-assisted visualization and segmentation, and target export creation and selection of structural MRI images, where an output can be generated for use by a system capable of reading DICOM image sets. Bullsai is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white matter tracts based on diffusion reconstruction methods and for the use of said maps to select and create exports. Typical users of Bullsai are medical professionals, including but not limited to surgeons, clinicians, and radiologists.

Source page: https://510kreport.com/device/K241094
Methodology: https://510kreport.com/methodology