# K173378: syngo®.via protoNeo (Version VA20)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Nov 20, 2017 after 21 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: 13 generations back to K913770 (1991). 183 ancestors in all.
No later device cites it as a predicate yet.
3 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161685: syngo®.via protoNeo (Version VA10A), Siemens Healthcare GmbH (2016) Summary page 4.

## Indications for use
syngo.via protoNeo 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 protoNeo supports interpretation and evaluation of examinations within healthcare institutions’ network, 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/K173378
Methodology: https://510kreport.com/methodology