| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-06-12 | K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | Radiology |
| 2025-08-26 | K251983 | Brainomix 360 Triage Stroke | Brainomix Limited | Radiology |
| 2025-02-14 | K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | Radiology |
| 2025-01-06 | K242123 | Brainomix 360 e-CTA | Brainomix Limited | Radiology |
| 2023-11-21 | K232496 | Brainomix 360 Triage Stroke | Brainomix Limited | Radiology |
| 2023-09-28 | K231837 | Brainomix 360 Triage LVO | Brainomix Limited | Radiology |
| 2023-07-27 | K231195 | Brainomix 360 Triage ICH | Brainomix Limited | Radiology |
| 2023-02-23 | K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | Radiology |