# K143196: syngo.CT Lung CAD

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: May 12, 2015 after 187 days
- Product code: OEB (Lung Computed Tomography System, Computer-Aided Detection)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063877 (2006). 1 ancestor in all.
18 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063877: Syngo Lung Cad, Siemens Medical Solutions USA, Inc. (2006) Summary page 5.

## Most influential descendants
- K163341: syngo.CT Extended Functionality (2017), 6 descendants of its own
- K193216: syngo.CT Lung CAD (2020), 5 descendants of its own
- K173625: syngo.CT Clinical Extensions (2018), 5 descendants of its own
- K161201: ClearRead CT (2016), 5 descendants of its own
- K203258: syngo.CT Lung CAD (2021), 4 descendants of its own

## Indications for use
The syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may have been initially overlooked. The syngo.CT Lung CAD device is intended to be used as a second reader after the radiologist has completed his/her initial read.

Source page: https://510kreport.com/device/K143196
Methodology: https://510kreport.com/methodology