Syngo.VIA
by Siemens AG Medical Solutions 510(k)
Active
510(k) K123920
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123920 | Date18 Jan 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Syngo.VIA is a radiological image post-processing software platform designed for multi-modality medical imaging analysis. It integrates diagnostic workflows across modalities such as CT, MRI, PET, and nuclear medicine to enable advanced visualization, quantification, and fusion of imaging data. The system supports 3D reconstruction and AI-assisted tools to enhance diagnostic accuracy and efficiency in radiology settings. Its primary function is to streamline interpretation and reporting for clinicians in oncology, cardiology, neurology, and nuclear medicine.
Syngo.VIA is supplied as a software solution installed on compatible radiology workstations, requiring no sterility or single-use considerations. It is intended for use in hospital or clinical radiology departments and is classified under FDA product code LLZ with a Traditional 510(k) clearance (K123920). The software is not MRI-safe or -unsafe but operates within standard IT infrastructure, with no specified sterility or reuse constraints. Authorized by Siemens AG Medical Solutions, it adheres to regulatory submissions filed with the FDA’s Radiology (RA) Advisory Committee.
Other devices from Siemens Medi Cal Solutions, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is Syngo.VIA used for in clinical settings?
Syngo.VIA is a radiological image post-processing software platform designed to streamline multi-modality imaging analysis. It integrates data from CT, MRI, PET, and nuclear medicine to enable advanced visualization, quantification, and fusion of imaging results. This enhances diagnostic accuracy and efficiency for clinicians specializing in oncology, cardiology, neurology, and nuclear medicine by providing tools for 3D reconstruction and AI-assisted analysis.
How is Syngo.VIA supplied and does it require sterility?
Syngo.VIA is supplied as a software solution installed on compatible radiology workstations. Since it is purely software-based, there are no sterility requirements or single-use constraints. It operates within standard IT infrastructure and does not involve physical devices that require sterilization.
Is Syngo.VIA intended for single-use or reusable applications?
Syngo.VIA is not designed for single-use or reusable physical components. As a software platform, it is installed on workstations and remains functional for ongoing use in radiology departments. The software itself does not degrade or require replacement, but updates may be applied to ensure compatibility and performance.
What regulatory approval does Syngo.VIA hold?
Syngo.VIA holds FDA clearance under Traditional 510(k) with the clearance number K123920. The device was classified under product code LLZ and was reviewed by the FDA’s Radiology (RA) Advisory Committee. It was determined to be substantially equivalent to a predicate device, allowing it to enter the market legally in the U.S.
Where can Syngo.VIA be used, and what are its compatibility requirements?
Syngo.VIA is intended for use in hospital or clinical radiology departments where multi-modality imaging is performed. It requires installation on compatible radiology workstations with standard IT infrastructure. While it does not have MRI-specific safety classifications (neither safe nor unsafe), it must operate within the existing IT systems of the facility to process and analyze imaging data effectively.