# K123375: Syngo.Via

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG
- Decided: Nov 20, 2012 after 19 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
96 later devices descend from it; 3 cite it directly.
1 of 97 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K092551: Smith & Nephew Instrument Trays, Smith & Nephew Inc., Endoscopy Div. (2010). Our reading of the summary gave K092551, FDA’s number for Smith & Nephew Instrument Trays (Smith & Nephew Inc., Endoscopy Div.). Its FDA name has none of the distinctive words the summary uses for the device it names, “syngo.x”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K123920: Syngo.Via (2013), 63 descendants of its own
- K130749: Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular (2013), 54 descendants of its own
- K150843: syngo®.via (version VB10A) (2015), 46 descendants of its own
- K133401: Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General (2014), 27 descendants of its own
- K151353: syngo.MR Neurology, syngo.MR Oncology (2015), 25 descendants of its own

## Recalls of this device
- Mar 27, 2018 · Class II · Z-1778-2018: Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor
- Jan 10, 2018 · Class II · Z-1261-2018: When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data bei
- Jan 8, 2018 · Class II · Z-1303-2018: A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and savi
- Aug 31, 2017 · Class II · Z-0808-2018: A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent di
- Mar 6, 2017 · Class II · Z-1689-2017: Software changes now available to address several issues
- Aug 5, 2016 · Class II · Z-2853-2016: Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
- Jun 23, 2016 · Class II · Z-2245-2016: Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.
- May 15, 2015 · Class II · Z-1705-2015: measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.

## Indications for use
syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo.via supports interpretation and evaluation of examinations within healthcare institutions; for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Source page: https://510kreport.com/device/K123375
Methodology: https://510kreport.com/methodology