# K233875: Brainomix 360 e-Lung

- Pathway: 510(k) (Traditional)
- Applicant: Brainomix Limited
- Decided: May 13, 2024 after 158 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K954355 (1995). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200990: VIDAvision, Vida Diagnostics, Inc. (2020) Summary page 4.

## Most influential descendants
- K242411: Brainomix 360 e-Lung (2025), 0 descendants of its own

## Indications for use
The e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and visualization tool for the assessment of CT thoracic datasets. e-Lung can be used to support the physician when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. 3D segmentation, volumetric measurements, density evaluations, and reporting tools are combined with a dedicated workflow.

Source page: https://510kreport.com/device/K233875
Methodology: https://510kreport.com/methodology