syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.syngo.via MI Workflows, including Scenium and syngo MBF, is software that helps healthcare professionals analyze medical images from multiple modalities such as PET, SPECT, CT, and MR. It aids disease management in oncology, cardiology, neurology, and organ function by providing tools for image viewing, quantification, comparison, and radiotherapy planning. The software integrates advanced AI algorithms for automating organ segmentation and supports new workflows such as tau quantification in brain imaging, thus improving diagnostic and treatment planning efficiency.
Intended Use
Medical diagnostic software for viewing, manipulation, quantification, analysis, and comparison of medical images from one or multiple imaging modalities and time-points in diseases including oncology, cardiology, neurology, and organ function; also supports radiotherapy treatment planning.
Technology
Software-only device with client/server architecture supporting DICOM data integration from PET, NM, CT, and MR; incorporates AI-based deep image-to-image neural network for organ segmentation and tau PET quantification workflow; hosted on standard IT hardware as part of the syngo.via platform; distributed electronically.
Performance
Validation through software verification and validation ensuring conformance to specifications; non-clinical testing demonstrating accuracy of deep-learning organ segmentation and correlation of tau PET quantification workflow with established MRI-based methods; no clinical trials conducted; risk management completed to mitigate identified hazards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/5/2023
4 months - 2
FDA Approval
11/28/2023
Other devices from Siemens Medical Solutions USA, Inc.
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