# K192692: Brainomix 360 e-CTA

- Pathway: 510(k) (Traditional)
- Applicant: Brainomix Limited
- Decided: May 28, 2020 after 245 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: 12 generations back to K896095 (1990). 13 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172477: iSchemaView RAPID, Ischemaview, Inc. (2018) Summary page 4.

## Most influential descendants
- K241975: Serv Medical CDSS (2025), 0 descendants of its own
- K242123: Brainomix 360 e-CTA (2025), 0 descendants of its own
- K213986: CerebralGo Plus (2023), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K192692
Methodology: https://510kreport.com/methodology