# K163341: syngo.CT Extended Functionality

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 9, 2017 after 72 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: 9 generations back to K954678 (1996). 89 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112020: Syngo.CT Vascular Analysis, Siemens Medi Cal Solutions, Inc. (2011) Summary page 5.
- K143196: syngo.CT Lung CAD, Siemens AG Medical Solutions (2015) Summary page 5.
- K971054: Osteo CT for the Somatom AR Family and Plus 4 CT Systems, Siemens Medical Solutions USA, Inc. (1997) Summary page 5.
- K053024: Syngo Neuro Dsa CT, Siemens AG (2005) Summary page 5.

## Most influential descendants
- K173625: syngo.CT Clinical Extensions (2018), 5 descendants of its own
- K192402: syngo.CT Extended Functionality (2019), 4 descendants of its own
- K203699: syngo. CT Extended Functionalities (2021), 3 descendants of its own
- K214019: syngo.CT Extended Functionality (2022), 1 descendant of its own
- K221727: syngo.CT Extended Functionality (2022), 0 descendants of its own

## Indications for use
syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners. An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system. Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.

Source page: https://510kreport.com/device/K163341
Methodology: https://510kreport.com/methodology