# K113029: Syngo Via MI Workflows

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 18, 2011 after 38 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: 10 generations back to K913770 (1991). 135 ancestors in all.
20 later devices descend from it; 1 cites 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)
- K092519: Syngo.X, Siemens AG Medical Solutions (2009) Summary page 2.
- K093621: Syngo.Pet&CT Oncology, Siemens Medical Solutions USA, Inc. (2010) Summary page 2.

## Most influential descendants
- K123577: Syngo.Via MI Workflows (2013), 19 descendants of its own
- K133644: Syngo.Via MI Workflows (2014), 18 descendants of its own
- 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

## Indications for use
syngovia Ml 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. syngovio MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngovia Ml Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngovia Vil 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.vio MI Workflows are a complement to these standard procedures.

Source page: https://510kreport.com/device/K113029
Methodology: https://510kreport.com/methodology