# K082430: Syngo Imaging XS

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Nov 14, 2008 after 84 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945188 (1995). 7 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071114: Syngo Imaging (Version V30), Siemens AG Medical Solutions (2007) Summary page 3.
- K072205: Visage Pacs/CS, Release Version 5.0, Mercury Computer Systems, Inc. (2007) Summary page 3.

## Most influential descendants
- K093612: Syngo.Plaza (2010), 10 descendants of its own
- K101666: Syngo. Plaza VA20A (2010), 9 descendants of its own
- K132532: Syngo.Plaza VB10A (2013), 8 descendants of its own
- K142750: JiveX (2015), 6 descendants of its own
- K162008: JiveX (2016), 4 descendants of its own

## Recalls of this device
- Nov 17, 2015 · Class II · Z-0550-2016: For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction with a printer not rele
- Nov 11, 2014 · Class II · Z-0576-2015: Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may hap
- Jun 30, 2014 · Class II · Z-2111-2014: Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region 
- Jul 18, 2012 · Class II · Z-2264-2012: There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Region
- Jan 26, 2012 · Not classified · Z-1064-2012: In September 2011 firm issued two Customer Safety Advisory Notices for syngo Imaging XS. Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Se
- Sep 20, 2011 · Not classified · Z-0514-2012: Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system.
- Sep 19, 2011 · Not classified · Z-0515-2012: Unintended behavior when using syngo Imaging XS, versions VA70A and VA70B Client/Serve installations. Loading additional images/series from Patient Browser using the thumbnails can cause an unintended
- Apr 6, 2010 · Not classified · Z-1892-2010: Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creati
- Feb 16, 2010 · Not classified · Z-1423-2010: images can be overwritten
- Sep 30, 2009 · Not classified · Z-0174-2010: Incomplete amount of image data; specifically, The image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archive
- Sep 29, 2009 · Not classified · Z-0270-2010: Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other 
- Sep 29, 2009 · Not classified · Z-0271-2010: Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other 

## Indications for use
syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. syngo Imaging XS also supports storage and archiving of Structured DICOM Reports. In a comprehensive imaging suite syngo Imaging XS integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo Imaging XS optionally uses a variety of advanced postprocessing applications. Note: Web based image distribution is not intended for reporting. syngo Imaging XS does not support the display of mammography images for diagnosis.

Source page: https://510kreport.com/device/K082430
Methodology: https://510kreport.com/methodology