BriefCase for ICH, PE and CSF Triage
BriefCase is a radiological computer aided triage and notification software device. The device contains the software platform and image analysis algorithms for ICH, PE and CSF triage.
1manufacturer
1catalogue number
25510(k) clearances naming this product code
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 |
| Record published | 2019-11-17 |
| Record revised | 2026-02-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Distribution end date | 2021-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.0.0 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Viz LVO | Viz.ai, Inc. | 12 |
| Triage Stroke | Brainomix Limited | 5 |
| BriefCase Triage | Aidoc Medical Ltd. | 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 |
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.