Oxford, GB · 13 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | Class II | Radiology | 4 | 2025-08-26 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 4 | 2025-01-06 |
| JAK | System, X-Ray, Tomography, Computed | Class II | Radiology | 2 | 2025-02-19 |
| POK | — | — | — | 2 | 2025-02-14 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 1 | 2026-06-12 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-12 | K260406 | Brainomix 360 Hyperdensity | QIH | Class II | Radiology |
| 2025-08-26 | K251983 | Brainomix 360 Triage Stroke | QAS | Class II | Radiology |
| 2025-02-19 | K242411 | Brainomix 360 e-Lung | JAK | Class II | Radiology |
| 2025-02-14 | K243294 | Brainomix 360 e-ASPECTS | POK | — | — |
| 2025-01-06 | K242123 | Brainomix 360 e-CTA | LLZ | Class II | Radiology |
| 2024-05-13 | K233875 | Brainomix 360 e-Lung | JAK | Class II | Radiology |
| 2023-11-21 | K232496 | Brainomix 360 Triage Stroke | QAS | Class II | Radiology |
| 2023-09-28 | K231837 | Brainomix 360 Triage LVO | QAS | Class II | Radiology |
| 2023-08-30 | K231656 | Brainomix 360 e-MRI | LLZ | Class II | Radiology |
| 2023-07-27 | K231195 | Brainomix 360 Triage ICH | QAS | Class II | Radiology |
| 2023-06-01 | K223555 | Brainomix 360 e-CTP | LLZ | Class II | Radiology |
| 2023-02-23 | K221564 | Brainomix 360 e-ASPECTS | POK | — | — |
| 2020-05-28 | K192692 | Brainomix 360 e-CTA | LLZ | Class II | Radiology |