syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.The syngo.via MI Workflows, including Scenium and syngo MBF, is a multi-modality software platform developed to assist healthcare professionals in viewing, manipulating, quantifying, and analyzing medical images from various imaging modalities, including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids physicians in radiotherapy treatment planning by harmonizing PET data and providing standardized analysis tools such as brain amyloid quantification.
Intended Use
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. Supports PET, nuclear medicine, CT, and MR modalities, and can perform harmonization of SUV (PET) across different systems or reconstruction methods. Intended for use by trained healthcare professionals to aid in management of diseases in oncology, cardiology, neurology, and organ function. Also supports radiotherapy treatment planning.
Technology
Software-only medical device for multi-modality post-processing including PET, SPECT, CT, and MR images. It employs a client/server architecture integrated with hospital IT systems for automatic or manual data import. Includes workflows for oncology, general MI, neurology (Scenium), and cardiology (syngo MBF). It provides harmonization of PET data and Centiloid standardized amyloid quantification. Supports DICOM data transfer and is distributed electronically.
Performance
Verification and validation testing confirmed the software meets all acceptance criteria including device hazards, with continued conformance to FDA special controls for software devices. Clinical performance evaluation demonstrated strong agreement for Centiloid amyloid quantification compared to established methods with excellent sensitivity and specificity in a study of patients with Mild Cognitive Impairment. Risk analysis and standards conformance were documented demonstrating safety and effectiveness comparable to predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/1/2024
29 days - 2
FDA Approval
8/30/2024
Other devices from Siemens Medical Solutions USA, Inc.
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