syngo.via MI WorkFlows, Scenium, syngo MBF
Siemens Medical Solutions USA, Inc.The syngo.via MI WorkFlows, including Scenium and syngo MBF, is a software suite from Siemens designed to assist healthcare professionals by providing advanced image processing, visualization, and quantitative analysis for multiple medical imaging modalities such as PET, CT, MRI, and SPECT. It supports disease management in oncology, cardiology, neurology, and organ function, helping clinicians interpret complex images and plan treatments more effectively.
Intended Use
syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points, including functional and anatomical datasets to aid in disease management and radiotherapy planning.
Technology
Software-only medical device that provides multi-modality post-processing capabilities for functional and anatomical imaging data, running on IT hardware via the Siemens syngo.via platform. Features include workflow-specific tools for oncology, cardiology, and neurology such as image visualization, segmentation, quantification, and database comparison across PET, CT, MRI, and SPECT modalities.
Performance
Comprehensive software validation including verification and validation tests ensuring functionality as designed, performance requirements met, and hazard mitigations fully implemented. Risk management follows ISO 14971 and standards IEC 62304, EN ISO 13485. Cybersecurity controls are implemented per FDA guidance to prevent unauthorized access and data misuse.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/11/2021
1 month - 2
FDA Approval
6/10/2021
Other devices from Siemens Medical Solutions USA, Inc.
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