# K102150: Syngo Dynamics, Version 9.0

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 5, 2010 after 68 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K842308 (1984). 29 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081018: Syngo Dynamics Version 7.0, Siemens Medical Solutions (2008)

## Most influential descendants
- K123922: Syngo Dynamics (2013), 5 descendants of its own
- K171053: syngo Dynamics Version VA30 (2017), 4 descendants of its own
- K220832: syngo Dynamics (Version VA40E) (2022), 3 descendants of its own
- K222428: Syngo Dynamics (Version VA40F) (2022), 2 descendants of its own
- K242551: syngo Dynamics (Version VA41D) (2025), 1 descendant of its own

## Recalls of this device
- Jan 29, 2016 · Class II · Z-0826-2016: Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
- Jan 25, 2016 · Class II · Z-1183-2016: Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.
- Apr 3, 2014 · Class II · Z-1613-2014: Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
- Jan 27, 2014 · Class II · Z-1216-2014: Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different 
- Jun 10, 2013 · Class II · Z-1859-2013: Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at a
- Jul 13, 2012 · Class II · Z-2219-2012: If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.
- Mar 24, 2011 · Not classified · Z-2293-2011: If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread s

## Indications for use
syngo® Dynamics is a Picture Archiving and Communication System (PACS) Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. syngo® Dynamics is not intended to be used for reading of mammography images.

Source page: https://510kreport.com/device/K102150
Methodology: https://510kreport.com/methodology