Syngo Carbon Clinicals
Siemens Healthcare GmbHSyngo Carbon Clinicals is a software package that provides advanced visualization tools to help healthcare professionals prepare, measure, and analyze medical images from modalities such as CT and MRI. It supports manipulation and communication of clinical data, enabling qualitative and quantitative assessment to assist in diagnosis and treatment planning.
Intended Use
Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data acquired by medical imaging modalities (e.g., CT, MR). Supports qualitative and quantitative measurements and analysis.
Technology
Software plug-in providing advanced visualization tools such as cinematic rendering, lesion quantification, lung nodule marking, and manual calibration; integrates with SYNGO platform-based hosting applications. Uses deep learning for organ segmentation and cinematic volume rendering.
Performance
Non-clinical performance testing including verification and validation was conducted. Bench testing and phantom/reader studies support lesion quantification and organ segmentation algorithms, with no changes requiring new clinical studies. Testing confirms safety and effectiveness consistent with predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/15/2023
2 months - 2
FDA Approval
12/1/2023
Other devices from Siemens Healthcare GmbH
- Syngo Carbon Enterprise Access (VA40A)2024 • 510K
- AI-Rad Companion (Pulmonary)2024 • 510K
- syngo.CT Lung CAD (Version VD30)2023 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.