# K081734: Syngo Imaging (Version V31)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Jul 3, 2008 after 14 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971684 (1997). 13 ancestors in all.
177 later devices descend from it; 1 cites it directly.
1 of 191 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071114: Syngo Imaging (Version V30), Siemens AG Medical Solutions (2007) Summary page 3.
- K061964: Syngo Multimodality Workplace, Siemens AG Medical Solutions (2006) Summary page 3.

## Most influential descendants
- 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
- K150843: syngo®.via (version VB10A) (2015), 46 descendants of its own

## Recalls of this device
- Jul 25, 2017 · Class II · Z-0405-2018: Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
- 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.
- Jun 1, 2009 · Not classified · Z-1650-2009: Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.

## 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 clearance for mammography must be used. syngo®Imaging also supports storage and archiving of DICOM 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/K081734
Methodology: https://510kreport.com/methodology