Syngo Carbon Enterprise Access (VA40A)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240294 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 Carbon Enterprise Access (VA40A) is an enterprise imaging and reporting solution designed to improve patient care through image interpretation, reporting, Artificial Intelligence (AI), and Data Management. It provides extensive tooling and open data models across modalities in one integrated and user-friendly workspace.
The device is supplied by Siemens Healthcare GmbH and is authorized under FDA 510K and MDR regulations. It is designed for use in radiology settings and provides access to innovation platforms, open source functionality, and up-to-date software capabilities.
Frequently asked questions
What is the primary purpose of Syngo Carbon Enterprise Access (VA40A)?
Syngo Carbon Enterprise Access (VA40A) is an enterprise imaging and reporting solution designed to improve patient care through image interpretation, reporting, AI, and data management across different medical imaging modalities in one integrated workspace.
How is Syngo Carbon Enterprise Access (VA40A) supplied?
The device is supplied by Siemens Healthcare GmbH, with its headquarters located at Siemensstraße 3, 91301 Forchheim, Germany.
What regulatory authorizations does Syngo Carbon Enterprise Access (VA40A) have?
The device is authorized under FDA 510K and MDR regulations, indicating it meets specific regulatory requirements for medical devices in those jurisdictions.
In what type of healthcare setting is Syngo Carbon Enterprise Access (VA40A) designed to be used?
It is designed for use in radiology settings, providing clinicians with access to innovation platforms, open source functionality, and up-to-date software capabilities.
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 Enterprise Access - Siemens Healthineers, Syngo Carbon - Siemens Healthineers, Syngo Carbon Enterprise Access - Siemens Healthineers
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 | K240294 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (2)
- FDA 510(k) K240294 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026