# K132532: Syngo.Plaza VB10A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Healthcare
- Decided: Dec 9, 2013 after 119 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K971684 (1997). 25 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101666: Syngo. Plaza VA20A, Siemens AG Medical Solutions (2010) Summary page 2.

## Most influential descendants
- K142750: JiveX (2015), 6 descendants of its own
- K162008: JiveX (2016), 4 descendants of its own
- K181964: JiveX (2018), 3 descendants of its own
- K200703: JiveX (2020), 2 descendants of its own
- K212321: JiveX (Model Number / Release: 5.3) (2021), 1 descendant of its own

## Recalls of this device
- Feb 20, 2018 · Class II · Z-1700-2018: Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
- Feb 20, 2018 · Class II · Z-1699-2018: Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
- Aug 23, 2017 · Class II · Z-0524-2018: When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not 
- Aug 18, 2017 · Class II · Z-0495-2018: Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of
- May 22, 2017 · Class II · Z-0168-2018: Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has 
- Sep 6, 2016 · Class II · Z-2892-2016: Software upgrade to eliminate several issues
- Aug 2, 2016 · Class II · Z-2794-2016: 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 
- 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
- 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

## Indications for use
syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including maninographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo.plaza also supports DICOM Structured Reports. In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information Systems (HIS / RIS) to enable customer specific workflows. s)7igo.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting.

Source page: https://510kreport.com/device/K132532
Methodology: https://510kreport.com/methodology