# K191309: syngo.via MI Workflows VB40A, Scenium

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Soultions USA, Inc.
- Decided: Jul 19, 2019 after 66 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K913770 (1991). 142 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173897: syngo.via MI Workflows, Siemens Medical Solutions USA, Inc. (2018) Summary page 5.

## Most influential descendants
- K201195: syngo.via MI Workflows, syngo MBF (2020), 5 descendants of its own
- K211459: syngo.via MI WorkFlows, Scenium, syngo MBF (2021), 4 descendants of its own
- K232000: syngo.via MI Workflows; Scenium; syngo MBF (2023), 3 descendants of its own
- K201202: MI View&GO (2020), 3 descendants of its own
- K242275: syngo.via MI Workflows; Scenium; syngo MBF (2024), 2 descendants of its own

## Indications for use
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods. syngo.via MI workflows support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures. The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDGPET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

Source page: https://510kreport.com/device/K191309
Methodology: https://510kreport.com/methodology