# K092519: Syngo.X

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Aug 27, 2009 after 9 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K971684 (1997). 15 ancestors in all.
176 later devices descend from it; 11 cite it directly.
1 of 192 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081734: Syngo Imaging (Version V31), Siemens AG Medical Solutions (2008) Summary page 4.
- K072728: Syngo Multimodality Workplace, Siemens AG Medical Solutions (2008) Summary page 2.

## Most influential descendants
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K093621: Syngo.Pet&CT Oncology (2010), 54 descendants of its own
- K150843: syngo®.via (version VB10A) (2015), 46 descendants of its own
- K110366: Syngo.CT Cardiac Function (2011), 25 descendants of its own

## Recalls of this device
- Mar 6, 2017 · Class II · Z-1688-2017: Software changes now available to address several issues
- Aug 5, 2016 · Class II · Z-2852-2016: Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
- Jun 23, 2016 · Class II · Z-2245-2016: Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.
- May 15, 2015 · Class II · Z-1705-2015: measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.

## Indications for use
syngo.x 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.x based software options. syngo.x 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/K092519
Methodology: https://510kreport.com/methodology