Viz LVO ContaCT
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Viz.ai, Inc.
Identifiers
- 510(k) Number
- K223042 FDA 510(k)
- FDA Product Code
- QAS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2080 FDA 510(k)
- Regulation Number
- 892.2080 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Viz LVO ContaCT is a Radiological Computer-Assisted Triage and Notification Software designed to assist radiologists in identifying large vessel occlusion (LVO) cases. It integrates with imaging systems to flag potential LVOs in stroke patients, enabling faster triage and intervention decisions in emergency settings.
This software is supplied as a digital tool for use within radiology workflows, requiring compatibility with DICOM-enabled imaging systems. It is not a single-use or reusable physical device but a software application regulated under FDA 510(k) clearance (K223042) and EU MDR compliance. No sterility, physical size, or MRI safety considerations apply, as it operates purely in a digital environment.
Frequently asked questions
What clinical scenario is the Viz LVO ContaCT software designed to assist with in emergency radiology workflows?
The Viz LVO ContaCT is specifically designed to assist radiologists in identifying large vessel occlusion (LVO) cases in stroke patients. By integrating with DICOM-enabled imaging systems, it flags potential LVOs to help expedite triage and intervention decisions, ensuring faster response times in emergency settings.
How is the Viz LVO ContaCT supplied, and what kind of imaging systems does it require for use?
The Viz LVO ContaCT is supplied as a digital software application, not a physical device. It requires compatibility with DICOM-enabled imaging systems to function within radiology workflows, enabling seamless integration for identifying LVOs in stroke imaging.
Is the Viz LVO ContaCT a single-use or reusable product, and does it have any physical size or sterility requirements?
The Viz LVO ContaCT is neither single-use nor reusable—it is a standalone software tool with no physical form, size, or sterility considerations. Since it operates entirely in a digital environment, these factors do not apply.
What regulatory pathways has the Viz LVO ContaCT followed for approval, and which governing bodies have cleared or authorized it?
The Viz LVO ContaCT has undergone FDA clearance via a 510(k) submission (K223042) and complies with EU Medical Device Regulation (MDR). It is classified under FDA’s device class 2 and falls under the Radiology specialty, with a special clearance type.
Does the Viz LVO ContaCT have any limitations related to MRI safety or physical compatibility with other medical equipment?
No, the Viz LVO ContaCT does not involve physical hardware or MRI-related components, so it has no MRI safety concerns or compatibility issues with other medical devices. It operates exclusively as a digital tool within radiology workflows.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223042 | Class II | Active |
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Manufacturer
- Manufacturer
- Viz.ai, Inc.
- FDA Applicant
- Viz. Ai, Inc.
Sources (2)
- FDA 510(k) K223042 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026