e-CTA
- Primary DI
- B720BX360ECTA1420
- Company
- BRAINOMIX LIMITED
- Model
- 14.2
- Published
- 2026-02-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Regulatory Flags
- DUNS number
- 216967482
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B720BX360ECTA1420 | Primary | HIBCC | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| B720BX360ECTA1420 | Primary | HIBCC | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 2 | Radiology | 892.2050 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|---|
| X-ray image interpretive software | An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format]. |
Device Sizes
No records found.
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
Contacts
No records found.
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B720BX360EASPECTS1420 | e-ASPECTS | 14.2 | 2026-02-03 | |
| B720BX360ECTP1420 | e-CTP | 14.2 | 2026-02-03 | |
| B720BX360EMRI1420 | e-MRI | 14.2 | 2026-02-03 | |
| B720BX360TRIAGESTRO142 | Triage Stroke | 14.2 | 2026-02-03 | |
| B720BX360TRIAGESTRO141 | Triage Stroke | 14.1 | 2025-11-28 | |
| B720BX360EASPECTS1400 | e-ASPECTS | 14.0 | 2025-08-18 | |
| B720BX360ECTA1400 | e-CTA | 14.0 | 2025-08-18 | |
| B720BX360ECTP1400 | e-CTP | 14.0 | 2025-08-18 | |
| B720BX360TRIAGEICH1400 | Triage ICH | 14.0 | 2025-08-18 | |
| B720BX360TRIAGELVO1400 | Triage LVO | 14.0 | 2025-08-18 | |
| B720BX360TRIAGESTRO1400 | Triage Stroke | 14.0 | 2025-08-18 | |
| B720BX360ELUNG220 | e-Lung | 2.2 | 2025-07-25 | |
| B720BX360EASPECTS113 | e-ASPECTS | 11.3 | 2025-04-15 | |
| B720BX360ELUNG210 | e-Lung | 2.1 | 2025-04-15 | |
| B720BX360ECTA1130 | Brainomix 360 e-CTA | 11.3 | 2025-03-20 | |
| B720BX360ELUNG100 | e-Lung | 1.0 | 2024-06-14 | |
| B720BX360TRIAGESTRO1120 | Triage Stroke | 11.2 | 2023-12-07 | |
| B720BX360TRIAGELVO1110 | Triage LVO | 11.1 | 2023-10-03 | |
| B720BX360EMRI1110 | e-MRI | 11.1 | 2023-09-05 | |
| B720BX360TRIAGEICH1110 | Triage ICH | 11.1 | 2023-09-05 |