Syngo Carbon Space VA30A
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230561 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 Carbon Space VA30A is a medical imaging software platform designed for radiology workflows, integrating diagnostic tools, visualization, and reporting into a unified workspace. It supports advanced imaging analysis, AI-assisted diagnostics, and seamless data management for routine and complex cases. As a radiology-specific solution, it enhances efficiency by consolidating imaging data, software modules, and clinical tools in a single interface. The system is optimized for workflow optimization, enabling radiologists to focus on patient care through intuitive navigation and intelligent features. Its modular architecture accommodates a wide range of imaging modalities and diagnostic applications.
The Syngo Carbon Space VA30A is supplied as a software solution for radiology departments, requiring compatible hardware infrastructure for operation. It is intended for single-use in clinical environments, though its software nature allows for updates and version upgrades. The device is not classified as MRI-safe or MRI-conditional, as it is a non-imaging software platform. No specific sterility or single-use packaging is applicable; instead, it is deployed on validated IT systems within healthcare facilities. Authorized under FDA 510(k) and MDR, it adheres to regulatory standards for medical imaging software in radiology settings.
Frequently asked questions
What types of radiology workflows is the Syngo Carbon Space VA30A designed to support, and how does it improve efficiency for radiologists?
The Syngo Carbon Space VA30A is a radiology-specific software platform that integrates diagnostic tools, visualization, and reporting into a single workspace. It supports advanced imaging analysis, AI-assisted diagnostics, and seamless data management for both routine and complex cases. By consolidating imaging data, software modules, and clinical tools, it optimizes workflows and enables radiologists to navigate patient cases more intuitively, reducing manual effort and allowing them to focus more on patient care.
Is the Syngo Carbon Space VA30A compatible with all imaging modalities, or does it require specific hardware to function?
The Syngo Carbon Space VA30A is a software solution designed to work within radiology departments but requires compatible hardware infrastructure for operation. While it supports a wide range of imaging modalities and diagnostic applications, its functionality depends on the underlying IT systems and hardware validated for its deployment. It is not a standalone device but rather an application that integrates with existing medical imaging equipment.
How is the Syngo Carbon Space VA30A deployed in clinical settings, and what does its software nature mean for updates and maintenance?
The Syngo Carbon Space VA30A is deployed on validated IT systems within healthcare facilities rather than being packaged in physical single-use or sterile form. Because it is a software platform, updates and version upgrades are handled through authorized software distribution channels, ensuring radiology departments can access the latest features and improvements without replacing hardware. This also means it does not require traditional sterilization or disposal processes.
Since the Syngo Carbon Space VA30A is not MRI-safe or MRI-conditional, how does this affect its use in facilities with MRI equipment?
The Syngo Carbon Space VA30A is explicitly classified as a non-imaging software platform, meaning it does not interact with MRI machines or operate within an MRI environment. Its use is confined to radiology workflows on validated IT systems, so it does not need to comply with MRI safety standards. However, it must still be deployed in a way that aligns with the facility’s broader IT and imaging infrastructure, ensuring seamless integration with other diagnostic tools.
What regulatory pathways does the Syngo Carbon Space VA30A follow, and how does this impact its adoption in different markets?
The Syngo Carbon Space VA30A has been authorized through the FDA’s 510(k) pathway and the EU’s Medical Device Regulation (MDR). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device in the U.S. and compliance with EU medical device standards. Clinicians and facilities can rely on these authorizations to ensure the software meets established safety and performance criteria, facilitating adoption in both markets while adhering to local regulatory requirements.
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 Carbon Space - Siemens Healthineers, Syngo Carbon - Siemens Healthineers, Syngo Carbon Space - Siemens Healthineers USA
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 | K230561 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (2)
- FDA 510(k) K230561 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 29, 2026