# K191040: syngo.via (Version VB40A)

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare GmbH
- Decided: May 16, 2019 after 27 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). 182 ancestors in all.
10 later devices descend from it; 3 cite it directly.
4 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150843: syngo®.via (version VB10A), Siemens AG (2015) Summary page 4.

## Most influential descendants
- K213665: Syngo Carbon Space VA20A (2022), 5 descendants of its own
- K230561: Syngo Carbon Space VA30A (2023), 4 descendants of its own
- K250443: MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile (2025), 2 descendants of its own
- K252838: MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise (2025), 1 descendant of its own
- K232856: Syngo Carbon Clinicals (2023), 1 descendant of its own

## Indications for use
syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo .via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Source page: https://510kreport.com/device/K191040
Methodology: https://510kreport.com/methodology