Triage LVO 11.2
Triage LVO 11.2 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K231837 on 28 Sep 2023 and listed in FDA GUDID since 15 Oct 2025 (UDI-DI B720BX360TRIAGELVO1120), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB720BX360TRIAGELVO1120 | Date15 Oct 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231837 | Date28 Sep 2023 | StatusActive |
Official records
- FDA 510(k) database K231837
Across registries
- FDA 510(k) K231837 decided 28 Sep 2023 Active
- FDA GUDID UDI-DI B720BX360TRIAGELVO1120 listed 15 Oct 2025 Listed
Timeline
- Cleared FDA 510(k) K231837
- Listed FDA GUDID B720BX360TRIAGELVO1120
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Triage LVO
- Generic name
- X-ray image interpretive software
- Model / reference
- 11.2
- Primary DI / UDI-DI
- B720BX360TRIAGELVO1120
- 510(k) Number
- FDA product code
- QAS
- GMDN term
- X-ray image interpretive software
- Device class
- Class II
- Regulation number
- 892.2080
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code QAS (Radiological Computer-Assisted Triage And Notification Software).
- BriefCase-Triage CARE Multi-Triage CT by AIDOC MEDICAL LTD
- EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) by Ever Fortune.Ai, Co., Ltd.
- Methinks NCCT Stroke by Methinks Software, S.L
- Annalise Enterprise CTB Triage Trauma by Annalise-Ai Pty, Ltd.
- Heuron ICH by Heuron Co., Ltd.
- HealthICH by Zebra Medical Vision, Ltd.
- Rapid CTA 360 by iSchemaView, Inc.
- qER by Qure.Ai Technologies
- Rapid ICH by iSchemaView, Inc.
- Contact by Viz.Al, Inc.