Viz ICH
Viz ICH v1.11 (2025-09-29)
1manufacturer
2catalogue numbers in this listing
4510(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 | Viz.ai, Inc., United States |
|---|---|
| FDA product code | QAS |
| Device type | Radiological Computer-Assisted Triage And Notification Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K210209 |
| Record published | 2022-04-06 |
| Record revised | 2025-10-07 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-03-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Viz ICH Software | In distribution | |
| 1.3 | Withdrawn |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 |
| 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 |
|---|---|
| K223042 | 2022-10-21 |
| K220439 | 2022-07-25 |
| K210209 | 2021-03-23 |
| K193658 | 2020-03-18 |
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.