syngo.via View&GO
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- syngo.via View&GO EUDAMED
- Device Name
- MDR_05_FOR_SYNGO_SaMD_IIb EUDAMED
- Model / Reference
- MDR_05_FOR_SYNGO_SaMD_IIb EUDAMED11665773 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869995779 EUDAMED
- Basic UDI-DI
- 0405686901978WU EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
syngo.via View&GO is a software-as-a-medical-device (SaMD) classified as Class IIb, designed for viewing and managing multimodal medical imaging data. It integrates clinical tools within a user-friendly interface to facilitate diagnostic workflows across various imaging modalities, enabling healthcare professionals to access and interpret diagnostic information efficiently.
This standalone software solution is intended for self-installation on existing hardware and operates as a non-sterile, non-reusable digital tool. It is supplied with a Basic UDI (0405686901978WU) and is authorized under FDA 510K and MDR regulations. The device requires no reprocessing or sterilization and is not intended for implantable, measuring, or medicinal applications, adhering to standard device criteria.
Frequently asked questions
What types of medical imaging data can syngo.via View&GO handle for diagnostic workflows?
syngo.via View&GO is designed to integrate and manage multimodal medical imaging data, meaning it supports multiple imaging modalities such as CT, MRI, X-ray, and ultrasound. This allows healthcare professionals to view and analyze diagnostic information from different sources within a single, user-friendly interface, streamlining their workflow.
Is syngo.via View&GO a standalone software solution, and how is it installed?
Yes, syngo.via View&GO is a standalone software-as-a-medical-device (SaMD) solution. It is intended for self-installation on existing hardware, meaning it can be deployed on pre-existing systems without requiring additional infrastructure, simplifying integration into clinical environments.
How is syngo.via View&GO supplied, and what does this mean for its use in a clinical setting?
syngo.via View&GO is supplied as a non-sterile, non-reusable digital tool, which means it does not require sterilization or reprocessing between uses. Clinicians can rely on it directly without concerns about contamination or sterilization procedures, as it is designed for single-use in a digital context.
What regulatory pathways does syngo.via View&GO follow, and what does this imply for its use?
syngo.via View&GO is authorized under both FDA 510K and MDR (Medical Device Regulation) pathways, confirming its compliance with stringent regulatory standards in the U.S. and EU markets. This implies that it has undergone evaluation to ensure safety, performance, and effectiveness for its intended diagnostic use, providing confidence in its clinical application.
Does syngo.via View&GO require any special handling or storage conditions?
As a software-based solution, syngo.via View&GO does not require physical storage conditions like temperature control or specialized environments. However, it should be installed on compatible hardware with appropriate IT infrastructure to ensure optimal performance and data security, following standard IT best practices for medical software.
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 syngo .via View&GO Operator Manual, Siemens Healthineers Digital Marketplace, syngo.via View&GO IT Administration Online Training | Siemens ...
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221501 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K201477 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0405686901978WU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
- EUDAMED SRN
- DE-MF-000006122
Sources (2)
- EUDAMED b9aa4ad1-d3cf-4980-bab7-87e4f0764cd5 61 fields · synced Oct 7, 2026
- FDA 510(k) K221501 1 fields · synced May 18, 2026