# K053133: Syngo Dynamics, Version 5.0

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 5, 2005 after 27 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K950279 (1995). 28 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041029: Kinetdx, Siemens Medi Cal Solutions, Inc. (2004)
- K051649: Vericis Cardiovascular Image and Information System, Model 4.0, Camtronics Medical Systems (2005) Summary page 3.
- K050228: Agfa Heartlab Cardiovascular, Heartlab, Inc. (2005) Summary page 3.

## Most influential descendants
- K111319: Ibis Explorer and Markup Software (2011), 6 descendants of its own
- K122205: EXINI (2012), 5 descendants of its own
- K191262: aBSI (2019), 2 descendants of its own
- K211655: aPROMISE (2021), 1 descendant of its own
- K173444: Quantitative Total Extensible Imaging (QTxI) (2018), 1 descendant of its own

## Recalls of this device
- Jul 23, 2008 · Not classified · Z-0544-2009: If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.
- Jan 31, 2007 · Not classified · Z-0652-2007: The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a

## 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.

Source page: https://510kreport.com/device/K053133
Methodology: https://510kreport.com/methodology