# K243294: Brainomix 360 e-ASPECTS

- Pathway: 510(k) (Traditional)
- Applicant: Brainomix Limited
- Decided: Feb 14, 2025 after 119 days
- Product code: POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN170022 (2017). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221564: Brainomix 360 e-ASPECTS, Brainomix Limited (2023) Summary page 6.

## Indications for use
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The software automatically registers images and uses an atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) score. Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 24 hours from time last known well). Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to and excluded from the automated ASPECTS score, and a calculation of the voxel volume contributing to ASPECTS score. Limitations: 1. Brainomix 360 e-ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation. 2. The Brainomix 360 e-ASPECTS score should be only used for ischemic stroke patients following the standard of care. 3. Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21 years. 4. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation. 5. Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners. Contraindications/ Exclusions/Cautions: * Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate. * Hemorrhagic Transformation, Hematoma.

Source page: https://510kreport.com/device/K243294
Methodology: https://510kreport.com/methodology