HealthICH
3 catalogue numbers from 2.0.5, listed by Nano-X AI Ltd., Israel, under Radiological Computer-Assisted Triage And Notification Software. 1 manufacturer in China is registered for this product code.
1manufacturer
3catalogue numbers in this listing
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 | Nano-X AI 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) | K190424 |
| Record published | 2019-07-02 |
| Record revised | 2024-07-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Distribution end date | 2023-01-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.0.5 | In distribution | |
| 3.0.0 | In distribution | |
| 2.1.3 | Withdrawn |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 |
| 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
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.