# K071114: Syngo Imaging (Version V30)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: May 22, 2007 after 32 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
No predicates in its family tree.
181 later devices descend from it; 4 cite it directly.
1 of 182 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K052409: Silgimix Alginate Replacement Impression Material, Sultan Chemists, Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K021161: TSO3 Ozone Chemical Indicator, Technologies of Sterilization With Oxone, Tso3, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K081734: Syngo Imaging (Version V31) (2008), 177 descendants of its own
- K092519: Syngo.X (2009), 176 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K093621: Syngo.Pet&CT Oncology (2010), 54 descendants of its own

## Recalls of this device
- Jan 18, 2016 · Class II · Z-1349-2016: To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
- Oct 28, 2015 · Class II · Z-0319-2016: To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the softw
- Jun 11, 2015 · Class II · Z-1972-2015: During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
- Jan 12, 2009 · Not classified · Z-1235-2009: Incorrect and/or incomplete data: Several potential safety issues while working with the syngo Image product including, but not limited to, data loss, errors in patient data due to different patient I
- Aug 22, 2008 · Not classified · Z-0102-2009: Image may not be visible after merge.
- Mar 10, 2008 · Not classified · Z-1643-2008: The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study.
- Nov 27, 2007 · Not classified · Z-0732-2008: Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high)

## 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. For primary image diagnosis in mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be used. Also only monitors which received FDA approval for mammography must be used. ,syngo®Imaging also supports storage and archiving of DJCOM Structured 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/K071114
Methodology: https://510kreport.com/methodology