# K052461: Syngo Imaging Version V20A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Sep 22, 2005 after 14 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: 5 generations back to K924178 (1993). 18 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042832: Sienet Cosmos (Version V15A), Siemens AG Medical Solutions (2004) Summary page 3.
- K040970: Leonardo, Siemens Medical Systems, Inc. (2004) Summary page 3.
- K042868: Mammoreport Softcopy Workstation, Siemens Medical Solutions USA, Inc. (2005) Summary page 3.

## Most influential descendants
- K070796: Chili Pacs (2007), 0 descendants of its own
- K060210: Mediport (2006), 0 descendants of its own

## Recalls of this device
- Apr 3, 2014 · Class II · Z-1622-2014: A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from
- Aug 22, 2008 · Not classified · Z-0102-2009: Image may not be visible after merge.
- Sep 5, 2006 · Not classified · Z-0070-2007: Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be 

## Indications for use
syngo®Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images. It supports the physician in diagnosis and treatment planning. syngo® Imaging also supports storage and archiving of Structured DICOM Reports. In a comprehensive imaging suite syngo®Imaging integrates Radiology Information Systems (RIS) to enable customer specific workflows. Enhanced syngo®Imaging workplaces use a variety of advanced postprocessing applications.

Source page: https://510kreport.com/device/K052461
Methodology: https://510kreport.com/methodology