# K133644: Syngo.Via MI Workflows

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 25, 2014 after 90 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: 12 generations back to K913770 (1991). 137 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123577: Syngo.Via MI Workflows, Siemens Medical Solutions USA, Inc. (2013) Summary page 2.

## Most influential descendants
- K151192: syngo.via MI Workflows (2015), 14 descendants of its own
- K160426: syngo.via MI Workflows (2016), 12 descendants of its own
- K163421: syngo.via MI Workflows (2017), 11 descendants of its own
- K173897: syngo.via MI Workflows (2018), 10 descendants of its own
- K191309: syngo.via MI Workflows VB40A, Scenium (2019), 9 descendants of its own

## Indications for use
syngovia 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 data sets, 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 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. syngovia MI Workflows support the interpretation and evaluation of examinations and followup 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.

Source page: https://510kreport.com/device/K133644
Methodology: https://510kreport.com/methodology