# K221564: Brainomix 360 e-ASPECTS

- Pathway: 510(k) (Traditional)
- Applicant: Brainomix Limited
- Decided: Feb 23, 2023 after 268 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: 2 generations back to DEN170022 (2017). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200760: Rapid ASPECTS, Ischemaview, Inc. (2020) Summary page 5.

## Most influential descendants
- K250221: StrokeSENS ASPECTS Software Application (2025), 0 descendants of its own
- K243294: Brainomix 360 e-ASPECTS (2025), 0 descendants of its own

## 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 with known MCA or ICA occlusion, 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 6 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 the automated ASPECTS score and the voxels excluded from the automated 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. Brainomix 360 e-ASPECTS has been validated in patients with known MCA or ICA occlusion prior to ASPECTS scoring. 3. Brainomix 360 e-ASPECTS is not suitable for use on brain scans displaying neurological pathologies other than acute stroke, such as tumours or abscesses, haemorrhagic transformation and hematoma. 4. Use of Brainomix 360 e-ASPECTS Module in clinical settings other than brain ischemia within 6 hours from time last known well, caused by known ICA or MCA occlusions has not been tested. 5. Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21. 6. Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners. 7. 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. Contraindications/Exclusions/Cautions: • Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate. • Haemorrhagic Transformation, Hematoma.

Source page: https://510kreport.com/device/K221564
Methodology: https://510kreport.com/methodology