| Primary Device ID | B720BX360ECTA1130 |
| NIH Device Record Key | 44b2d110-c1ca-4182-a26f-010095ede1f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Brainomix 360 e-CTA |
| Version Model Number | 11.3 |
| Company DUNS | 216967482 |
| Company Name | BRAINOMIX LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B720BX360ECTA1130 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-28 |
| Device Publish Date | 2025-03-20 |
| B720BX360ECTA1130 - Brainomix 360 e-CTA | 2025-03-28 |
| B720BX360ECTA1130 - Brainomix 360 e-CTA | 2025-03-28 |
| B720BX360ELUNG100 - e-Lung | 2024-06-24 |
| B720BX360TRIAGESTRO1120 - Triage Stroke | 2023-12-15 |
| B720BX360TRIAGELVO1110 - Triage LVO | 2023-10-11 |
| B720BX360EMRI1110 - e-MRI | 2023-09-13 |
| B720BX360TRIAGEICH1110 - Triage ICH | 2023-09-13 |
| B720BX360ECTP1110 - e-CTP | 2023-07-14 |
| B720BX360EASPECTS1110 - e-ASPECTS | 2023-04-14 |