Brainomix Limited
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories4
Latest Approval2025-08-26
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K251983 | Brainomix 360 Triage Stroke | QAS | 2025-08-26 | View |
| 510(k) | K242411 | Brainomix 360 e-Lung | JAK | 2025-02-19 | View |
| 510(k) | K243294 | Brainomix 360 e-ASPECTS | POK | 2025-02-14 | View |
| 510(k) | K242123 | Brainomix 360 e-CTA | LLZ | 2025-01-06 | View |
| 510(k) | K233875 | Brainomix 360 e-Lung | JAK | 2024-05-13 | View |
| 510(k) | K232496 | Brainomix 360 Triage Stroke | QAS | 2023-11-21 | View |
| 510(k) | K231837 | Brainomix 360 Triage LVO | QAS | 2023-09-28 | View |
| 510(k) | K231656 | Brainomix 360 e-MRI | LLZ | 2023-08-30 | View |
| 510(k) | K231195 | Brainomix 360 Triage ICH | QAS | 2023-07-27 | View |
| 510(k) | K223555 | Brainomix 360 e-CTP | LLZ | 2023-06-01 | View |
| 510(k) | K221564 | Brainomix 360 e-ASPECTS | POK | 2023-02-23 | View |
| 510(k) | K192692 | Brainomix 360 e-CTA | LLZ | 2020-05-28 | View |
No matching devices.