# K162541: syngo Application Software

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 16, 2016 after 65 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: 5 generations back to K010938 (2001). 5 ancestors in all.
35 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153346: syngo Application Software VD11, Siemens Medical Solutions USA, Inc. (2016) Summary page 5.

## Most influential descendants
- K163286: ARTIS pheno (2017), 23 descendants of its own
- K190768: ARTIS icono (2019), 10 descendants of its own
- K181550: Cios Spin (2018), 10 descendants of its own
- K181560: Cios Alpha (2018), 10 descendants of its own
- K163285: syngo Application Software (2017), 10 descendants of its own

## Indications for use
The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation, It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems of the Siemens Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems. The syngo Application Software can be configured with a varicty of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment planning and treatment control. It includes commercially available post-processing techniques and OEM options, Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

Source page: https://510kreport.com/device/K162541
Methodology: https://510kreport.com/methodology