# K093612: Syngo.Plaza

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Mar 4, 2010 after 101 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945188 (1995). 8 ancestors in all.
10 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)
- K082430: Syngo Imaging XS, Siemens AG Medical Solutions (2008) Summary page 3.

## Most influential descendants
- 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
- K181964: JiveX (2018), 3 descendants of its own

## Recalls of this device
- Feb 20, 2017 · Class II · Z-1533-2017: Software updates
- Jan 11, 2017 · Class II · Z-1116-2017: Software update for improvements and to resolve several issues
- Sep 6, 2016 · Class II · Z-2891-2016: Software upgrade to eliminate several issues
- Aug 2, 2016 · Class II · Z-2793-2016: Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and 
- May 9, 2016 · Class II · Z-2088-2016: Software error in previous software versions in which two references for the same image may exist in the database.
- Dec 22, 2015 · Class II · Z-0862-2016: Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in acces
- Jul 6, 2015 · Class II · Z-2719-2015: Potential issue leading to data loss and patient data mix-up
- Feb 18, 2015 · Class II · Z-1354-2015: Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived
- Jan 13, 2015 · Class II · Z-1027-2015: In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not 
- 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
- Mar 4, 2013 · Class II · Z-1975-2013: Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not
- Jun 20, 2012 · Class II · Z-0465-2013: Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues
- Jun 6, 2012 · Class II · Z-0048-2013: Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in
- Jan 20, 2012 · Not classified · Z-1127-2012: There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where data in Short-Term Storage (STS) could ream
- Sep 21, 2011 · Not classified · Z-0522-2012: Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet co
- Aug 8, 2011 · Class II · Z-0271-2014: The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affect

## Indications for use
syngo.plaza is a Picture Archiving and Conmunication 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. plaza also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo. plaza integrates Hospital/Radiology Informhation Systems (HIS/RIS) to enable customer specific workflows. syngo. plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image dihtribution is not intended for reporting. In the U.S.A., syngo.plaza is not intended for the reporting of digital mammography images.

Source page: https://510kreport.com/device/K093612
Methodology: https://510kreport.com/methodology