# K242123: Brainomix 360 e-CTA

- Pathway: 510(k) (Traditional)
- Applicant: Brainomix Limited
- Decided: Jan 6, 2025 after 171 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: 15 generations back to K896095 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192692: Brainomix 360 e-CTA, Brainomix Limited (2020) Summary page 5.
- K233582: Rapid, Ischemaview, Inc. (2024) Summary page 5.

## Indications for use
Brainomix 360 e-CTA 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 standard "off the-shelf' hardware (physical or virtualized) and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. Brainomix 360 e-CTA provides viewing and analysis capabilities for imaging datasets acquired with CTA (CT Angiography). Brainomix 360 e-CTA is not intended for mobile diagnostic use. Brainomix 360 e-CTA vessel density asymmetry ratio applies only to the MCA region.

Source page: https://510kreport.com/device/K242123
Methodology: https://510kreport.com/methodology