# K201195: syngo.via MI Workflows, syngo MBF

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 18, 2020 after 198 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 18 generations back to K913770 (1991). 146 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K191309: syngo.via MI Workflows VB40A, Scenium, Siemens Medical Soultions USA, Inc. (2019) Summary page 5.
- K110494: Syngo MBF, Siemens Medical Solutions USA, Inc. (2011) Summary page 5.

## Most influential descendants
- 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
- K242275: syngo.via MI Workflows; Scenium; syngo MBF (2024), 2 descendants of its own
- K251528: syngo.via MI Workflows; Scenium; syngo MBF (2025), 1 descendant of its own
- K254016: MI View&GO (2026), 0 descendants of its own

## Indications for 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. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods. syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

Source page: https://510kreport.com/device/K201195
Methodology: https://510kreport.com/methodology