syngo.via MI Workflows, syngo MBF
Siemens Medical Solutions USA, Inc.syngo.via MI Workflows and syngo MBF are software applications by Siemens for advanced medical image processing and analysis. They work with various imaging modalities including PET, SPECT, CT, and MRI to help clinicians view, quantify, and compare images. The software supports disease management in oncology, cardiology, neurology, and organ function and also aids radiotherapy treatment planning.
Intended Use
An individual software program or group of programs that add specific image processing and analysis capabilities to PET and SPECT imaging system configurations, facilitating viewing, manipulation, quantification, and comparison of medical images from single or multiple modalities and time-points.
Technology
Software-only medical device delivered on CD/DVD to be installed on Siemens syngo.via platform. Supports visualization, quantification, comparison of multi-modality images (PET, SPECT, CT, MR). Includes workflows supporting oncology, cardiology, neurology. Builds on predicate devices syngo.via MI Workflows VB40A and syngo MBF 2.0 with added features such as Auto Lung 3D, cardiac masking, and FDOPA normals database.
Performance
Verification and validation activities ensure functions perform as designed with full implementation of hazard mitigations. Testing met acceptance criteria. Risk management followed ISO 14971 standards. Software development adheres to IEC 62304 and quality system regulations (21 CFR 820). Cybersecurity controls prevent unauthorized access and misuse.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/4/2020
6 months - 2
FDA Approval
11/18/2020
Other devices from Siemens Medical Solutions USA, Inc.
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