Syngo Carbon Enterprise Access (VA40A)
Siemens Healthcare GmbHSyngo Carbon Enterprise Access (VA40A) is a software-only medical device developed by Siemens Healthcare GmbH for use in healthcare institutions. It provides an enterprise-wide web application to display and render DICOM and non-DICOM medical data, supporting image and result distribution for diagnostic use by trained medical professionals. The software facilitates standardized data access without controlling image acquisition and enhances clinical workflows with a user-friendly interface. It does not include automated diagnostic functions but supports quality display and management of medical images and documents.
Intended Use
Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions.
Technology
Software-only device using client-server architecture installed on standard IT hardware, enabling viewing of DICOM and non-DICOM images and clinical documents via an enterprise-wide web application. Supports standard network protocols (TCP/IP, DICOM 2016a, HL7, FHIR) without controlling image acquisition devices.
Performance
Non-clinical performance testing conducted during product development included software verification and validation, risk analysis, and cybersecurity measures. Testing demonstrated functionality met acceptance criteria and device safety and effectiveness comparable to the predicate device (Syngo Carbon Space). No clinical studies were performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/1/2024
3 months - 2
FDA Approval
5/23/2024
Other devices from Siemens Healthcare GmbH
- AI-Rad Companion (Pulmonary)2024 • 510K
- Syngo Carbon Clinicals2023 • 510K
- syngo.CT Lung CAD (Version VD30)2023 • 510K
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