| Primary Device ID | B720BX360ECTA1400 |
| NIH Device Record Key | 5c83f369-e31a-4cd8-af93-ae52175e9b13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | e-CTA |
| Version Model Number | 14.0 |
| 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 | B720BX360ECTA1400 [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 | 2025-08-26 |
| Device Publish Date | 2025-08-18 |
| B720BX360ECTA1110 | 11.1 |
| B720BX360ECTA1400 | 14.0 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() E-CTA 79250460 not registered Live/Pending |
Brainomix Limited 2018-12-13 |