# K231656: Brainomix 360 e-MRI

- Pathway: 510(k) (Traditional)
- Applicant: Brainomix Limited
- Decided: Aug 30, 2023 after 84 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: 11 generations back to K896095 (1990). 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)
- K121447: Ischema View Rapid, Ischemaview, Inc. (2013) Summary page 4.

## Indications for use
Brainomix 360 e-MRI is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. This includes DICOM files uploaded through a web browser interface. Brainomix 360 e-MRI provides both viewing and analysis capabilities for imaging datasets acquired with MRI including Perfusion Weighted Imaging (PWI) and Diffusion Weighted Imaging (DWI1). The DWI MRI analysis capabilities are used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The MRI PWI analysis capabilities are for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

Source page: https://510kreport.com/device/K231656
Methodology: https://510kreport.com/methodology