syngo.via View&GO VA40A
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230196 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The syngo.via View&GO VA40A is a multimodality medical imaging software viewer designed for radiology workflows. It integrates diagnostic imaging data from various modalities, including X-ray, CT, MRI, and ultrasound, into a unified platform for visualization and analysis. This software enables radiologists and clinicians to access and interpret medical images efficiently within a familiar interface. Its classification aligns with Class II X-ray diagnostic devices under regulatory frameworks.
syngo.via View&GO VA40A is supplied as a standalone software solution for self-installation on compatible hardware, requiring no additional hardware modifications. It is intended for institutional use in radiology departments and imaging centers, where it supports diagnostic decision-making. The device has received FDA 510(k) clearance under the Radiology (RA) advisory committee and complies with MDR (Medical Device Regulation) standards. No sterility or single-use requirements apply, as it is a reusable software application.
Frequently asked questions
What types of medical imaging data can the syngo.via View&GO VA40A integrate and display for radiologists?
The syngo.via View&GO VA40A integrates and displays diagnostic imaging data from multiple modalities, including X-ray, CT (computed tomography), MRI (magnetic resonance imaging), and ultrasound. This allows radiologists to consolidate and analyze images from different sources in a single, unified platform for streamlined workflows and improved diagnostic accuracy.
Is the syngo.via View&GO VA40A designed for use in specific clinical settings, and how is it deployed?
Yes, the syngo.via View&GO VA40A is specifically designed for institutional use in radiology departments and imaging centers. It is supplied as a standalone software solution that can be self-installed on compatible hardware within these settings, requiring no additional hardware modifications or infrastructure changes.
How is the syngo.via View&GO VA40A regulated, and what does its classification mean for users?
The syngo.via View&GO VA40A is classified as a Class II X-ray diagnostic device under regulatory frameworks and has received FDA 510(k) clearance through the Radiology (RA) advisory committee. This classification means it undergoes rigorous review to ensure safety and effectiveness for diagnostic imaging purposes, while compliance with MDR (Medical Device Regulation) standards ensures adherence to European Union requirements.
Does the syngo.via View&GO VA40A require any special handling, such as sterility or single-use considerations?
No, the syngo.via View&GO VA40A is a reusable software application and does not have sterility or single-use requirements. Since it operates on compatible hardware within institutional settings, it is designed for repeated use by authorized personnel without any restrictions related to disposal or sterilization.
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. Sources consulted: syngo.via View&GO - Siemens Healthineers, PDF Siemens Healthcare GmBH ℅ Prithul Bom Most Responsible Person ..., syngo.via View&GO VA40A What's New Job Aid | Siemens Healthineers Academy, Siemens Syngo.via View&GO VA40A - allmed.wiki
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 | K230196 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (2)
- FDA 510(k) K230196 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 3, 2026