AccipioIx
AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage…
AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. AccipioIx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. AccipioIx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.
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 | Maxq AI Ltd |
|---|---|
| FDA product code | QAS |
| Device type | Radiological Computer-Assisted Triage And Notification Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2080 |
| 510(k) | K182177 |
| Record published | 2020-12-17 |
| Record revised | 2023-12-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V1.6 | In distribution | |
| V2.3 and subsequent minor V2.x releases | In distribution |
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 |
| 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.