# K071310: Syngo CT Oncology Software Package

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG
- Decided: Jun 8, 2007 after 30 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954678 (1996). 19 ancestors in all.
195 later devices descend from it; 7 cite it directly.
1 of 215 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022013: Lungcare CT Software Package, Siemens Medical Solutions USA, Inc. (2002) Summary page 2.
- K061696: Iqqa-Liver Software, Edda Technology, Inc. (2006) Summary page 2.
- K963345: Advantage Windows Tissue Volume Option, GE Medical Systems (1996) Summary page 2.
- K010938: Syngo Multimodality Workstation, Siemens Medical Solutions USA, Inc. (2001) Summary page 2.

## Most influential descendants
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 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

## Indications for use
syngo CT Oncology is a self-contained, non invasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of lesions and includes dedicated tools to support the physician in lung, liver and lymph node assessment in CT data. Dedicated workflow-support and integrated, accumulative reporting help to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).

Source page: https://510kreport.com/device/K071310
Methodology: https://510kreport.com/methodology