# K143319: Syngo X-workplace SW VD10

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Feb 24, 2015 after 97 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010938 (2001). 3 ancestors in all.
39 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042995: X-Leonardo, Siemens Medical Solutions USA, Inc. (2004) Summary page 5.

## Most influential descendants
- K153346: syngo Application Software VD11 (2016), 38 descendants of its own
- K162541: syngo Application Software (2016), 35 descendants of its own
- 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

## Recalls of this device
- Feb 24, 2016 · Class II · Z-1232-2016: After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
- Nov 18, 2015 · Class II · Z-0597-2016: Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner 

## Indications for use
The syngo X Workplace is a medical workstation 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 X Workplace can be configured as 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 X Workplace can be combined with systems of the Artis family. In combination with an Artis system., 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 X Workplace can also be combined with fluoroscopy systems or Radiographic systems. The syngo X Workplace can be configured with a variety 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/K143319
Methodology: https://510kreport.com/methodology