Syngo Carbon Clinicals (VA41)
510(k) K251059
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251059 | Date24 Oct 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
Syngo Carbon Clinicals (VA41) is a Radiology Information System (RIS) and Picture Archiving and Communication System (PACS) integration platform designed to streamline clinical workflows in radiology departments. It facilitates efficient image interpretation, visualization, reporting, and data management across multiple imaging modalities, enabling standardized access to diagnostic information and supporting AI-driven analytics within a unified workspace.
The device is supplied as a software solution for enterprise imaging environments, intended for use in radiology departments and clinical settings where digital radiology workflows are implemented. It is not classified as a single-use or reusable medical device but rather as a software application requiring installation on compatible IT infrastructure. No sterility or MRI safety classifications are specified, and its regulatory status is confirmed by FDA 510(k) clearance under the Radiology advisory committee, with a decision code of SESE (Substantially Equivalent).
From the manufacturer
Syngo Carbon gives rise to knowledge by providing a highly efficient, high quality and optimized clinical environment, opening up a wide range of possibilities in reading, visualization, reporting, AI implementation, data management, archiving and migration, including unique access to innovation platforms, open source and third party functionality and the most up-to-date software available.
Syngo Carbon 2 is a new enterprise imaging and reporting solution from Siemens Healthineers. Designed to improve patient care, Syngo Carbon opens possibilities in image interpretation, reporting, Artificial Intelligence (AI), and Data Management. Syngo Carbon provides extensive tooling and open data models across modalities in one integrated and user-friendly workspace.
Other devices from Siemens Healthineers AG
Questions
AI-generated answers, 20 Sep 2026
What types of clinical workflows does Syngo Carbon Clinicals (VA41) help streamline in radiology departments?
Syngo Carbon Clinicals (VA41) integrates a Radiology Information System (RIS) and Picture Archiving and Communication System (PACS) to optimize workflows for image interpretation, visualization, reporting, and data management. It supports standardized access to diagnostic information across multiple imaging modalities, including AI-driven analytics, all within a unified workspace. This helps radiologists and clinicians efficiently manage digital radiology workflows in enterprise imaging environments.
How is Syngo Carbon Clinicals (VA41) supplied and what kind of infrastructure does it require?
Syngo Carbon Clinicals (VA41) is supplied as a software solution rather than a physical device, meaning it requires installation on compatible IT infrastructure within radiology departments or clinical settings. It is not a single-use or reusable medical device, so it must be integrated into existing systems rather than disposed of or reprocessed after use.
Is Syngo Carbon Clinicals (VA41) approved for use in specific regulatory markets, and how was its clearance determined?
Yes, Syngo Carbon Clinicals (VA41) holds FDA 510(k) clearance under the Radiology advisory committee (decision code: SESE). The clearance was determined through a traditional review process, confirming it is *substantially equivalent* to a legally marketed predicate device. This means the FDA evaluated it based on existing standards for similar radiology software solutions.
Does Syngo Carbon Clinicals (VA41) support multiple imaging modalities, and how does it enhance diagnostic workflows?
While the description does not list specific modalities, Syngo Carbon Clinicals (VA41) is designed to integrate with *multiple imaging modalities* by providing a unified workspace for image interpretation, visualization, and reporting. This consolidation of diagnostic information across modalities—such as X-ray, CT, MRI, or ultrasound—helps reduce fragmentation in workflows, enabling faster, more accurate diagnoses and standardized access to patient data.