Vuno Med-Chest X-ray Triage
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by VUNO Inc.
Identifiers
- 510(k) Number
- K241439 FDA 510(k)
- FDA Product Code
- QFM 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 Vuno Med-Chest X-ray Triage is a Radiological Computer-Assisted Prioritization Software for Lesions, designed to assist radiologists in triaging and evaluating chest X-ray images. It employs automated algorithms to identify and prioritise potential abnormalities, enhancing diagnostic efficiency and workflow management in radiology settings.
This software is supplied as a digital solution, intended for use in clinical radiology departments with access to compatible imaging systems. It operates as a reusable, non-sterile tool, requiring no special storage conditions beyond standard IT infrastructure. The device holds FDA 510(k) clearance and MDR compliance, with regulatory classification under Class II (Device Class) and QFM product code (OpenFDA).
Frequently asked questions
What is the primary purpose of the VUNO Med-Chest X-ray Triage software in a clinical setting?
The VUNO Med-Chest X-ray Triage is designed to assist radiologists by automating the identification and prioritization of potential abnormalities in chest X-ray images. It enhances diagnostic efficiency and streamlines workflow management, helping radiologists focus on critical findings faster.
How is the VUNO Med-Chest X-ray Triage supplied, and what are its storage requirements?
The software is supplied as a digital solution, meaning it requires no physical storage beyond standard IT infrastructure. Since it is non-sterile and reusable, no special environmental conditions (like temperature or humidity control) are needed—only a compatible imaging system and active IT setup.
Is the VUNO Med-Chest X-ray Triage intended for single-use or repeated use across multiple patients?
The device is explicitly described as reusable, meaning it can be used repeatedly across different patients within a radiology department. This aligns with its classification as a software tool rather than a consumable or disposable item.
What regulatory pathways has the VUNO Med-Chest X-ray Triage followed, and what does that mean for its use?
The software holds both FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and effectiveness. Its classification as Class II (under OpenFDA’s *Radiological Computer-Assisted Prioritization Software for Lesions*) indicates it undergoes rigorous review but does not require the same stringent oversight as higher-risk devices.
Does the VUNO Med-Chest X-ray Triage require integration with specific imaging systems, and if so, which ones?
The device is intended for use in clinical radiology departments with *compatible imaging systems*, though the exact models or brands aren’t specified in the data. Compatibility would depend on the software’s technical requirements, which would typically be detailed in the manufacturer’s documentation or system integration guides.
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 | K241439 | Class II | Active |
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Manufacturer
- Manufacturer
- VUNO Inc.
- FDA Applicant
- Vuno, Inc.
Sources (2)
- FDA 510(k) K241439 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026