BriefCase Triage
BriefCase Triage is radiological computer-aided triage and notification software. It analyzes medical images to identify or prioritize cases for time-sensitive review and sends a…
BriefCase Triage is radiological computer-aided triage and notification software. It analyzes medical images to identify or prioritize cases for time-sensitive review and sends a notification into the clinical workflow. Notifications bring flagged cases to the attention of the care team.
The software supports radiology worklist prioritization by directing attention to flagged imaging studies. It is a triage and notification layer within the imaging workflow, rather than a standalone image-acquisition system.
Listed Item
BriefCase is a radiological computer aided triage and notification software
Triage Workflow
Aidoc describes a clinical AI software platform that analyzes imaging findings and helps prioritize review. FDA’s product definition describes QAS software as producing triage notifications for cases needing attention.
BriefCase Triage supports review prioritization. The software does not replace the radiologist’s interpretation or provide a final diagnosis.
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Record
| Listed by | Aidoc Medical Ltd., Israel |
|---|---|
| FDA product code | QAS |
| Device type | Radiological Computer-Assisted Triage And Notification Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2080 |
| Establishment | Manufacturer |
| 510(k) | K190896 |
| Record published | 2023-07-14 |
| Record revised | 2026-02-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19.x.y | In distribution | |
| 22.y.z | In distribution | |
| 23.y.z | In distribution | |
| 21.x.y | In distribution | |
| 24.y.z | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Viz LVO | Viz.ai, Inc. | 12 |
| Triage Stroke | Brainomix Limited | 5 |
| Triage LVO | Brainomix Limited | 5 |
| BriefCase | Aidoc Medical Ltd. | 3 |
| HealthICH | Nano-X AI Ltd. | 3 |
| Annalise Triage | Harrison-AI Medical Pty Ltd | 3 |
| Triage ICH | Brainomix Limited | 3 |
| syngo.CT Brain Hemorrhage | Siemens Healthcare Limited | 2 |
| AccipioIx | Maxq AI Ltd | 2 |
| Viz ICH | Viz.ai, Inc. | 2 |
| qER | Qure.ai Technologies Private Limited | 1 |
| Viz SDH (Viz Subdural) | Viz.ai, Inc. | 1 |
Showing 12 of 29. All products under Radiological Computer-Assisted Triage And Notification Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261317 | 2026-05-14 |
| K253578 | 2026-02-26 |
| K251195 | 2026-01-27 |
| K252970 | 2026-01-07 |
| K253265 | 2025-11-06 |
| K251406 | 2025-05-30 |
| K250248 | 2025-02-14 |
| K242837 | 2024-10-18 |
| K241727 | 2024-07-12 |
| K232751 | 2023-10-30 |
| K221330 | 2022-11-18 |
| K220709 | 2022-10-07 |
| K222329 | 2022-09-28 |
| K222277 | 2022-08-26 |
| K221314 | 2022-06-03 |
| K221240 | 2022-05-17 |
| K213886 | 2022-04-26 |
| K213721 | 2022-03-21 |
| K203508 | 2020-12-29 |
| K201020 | 2020-08-26 |
| K193298 | 2020-06-19 |
| K192383 | 2019-12-20 |
| K190896 | 2019-05-31 |
| K190072 | 2019-04-15 |
| K180647 | 2018-08-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.