syngo.via (Version VB40A)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191040 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)
syngo.via (Version VB40A) is an integrated imaging software platform designed for radiology workflows. As a Class II medical device, it serves as a centralized system for processing and analyzing radiographic images, supporting diagnostic tasks such as interpretation and reporting. The software integrates intelligent tools to enhance efficiency in routine radiology procedures, including image review and documentation. Its functionality aligns with the needs of radiology departments to manage increasing diagnostic workloads through streamlined digital processes.
syngo.via (Version VB40A) is supplied as a software solution for use in radiology departments, typically installed on hospital or clinic imaging systems. It is not described as single-use or reusable but operates within existing IT infrastructure, adhering to healthcare interoperability standards such as IHE (Integrating the Healthcare Enterprise). The device holds FDA 510(k) clearance under the product code LLZ, with a decision classification of Substantially Equivalent, and is also authorized under the Medical Device Regulation (MDR). No sterility or MRI safety specifications are noted, as it is a software-based system rather than a physical device.
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 - Siemens Healthineers, IHE - syngo.via - Siemens Healthineers, PDF syngo.via VB40A Datasheet, Siemens Syngo.via (Version Vb40a) - 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 | K191040 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (2)
- FDA 510(k) K191040 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 4, 2026