# K101666: Syngo. Plaza VA20A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Aug 10, 2010 after 57 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K971684 (1997). 24 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K093612: Syngo.Plaza, Siemens AG Medical Solutions (2010) Summary page 2.
- K071114: Syngo Imaging (Version V30), Siemens AG Medical Solutions (2007)
- K092519: Syngo.X, Siemens AG Medical Solutions (2009) Summary page 2.

## Most influential descendants
- 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
- K200703: JiveX (2020), 2 descendants of its own

## Recalls of this device
- Jul 18, 2012 · Class II · Z-2275-2012: There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
- Feb 24, 2012 · Class II · Z-2078-2012: Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer
- May 1, 2011 · Not classified · Z-0827-2012: The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that 

## Indications for use
svyngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic 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. .syngo.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/K101666
Methodology: https://510kreport.com/methodology