# K193216: syngo.CT Lung CAD

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Mar 9, 2020 after 109 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: 2 generations back to K063877 (2006). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143196: syngo.CT Lung CAD, Siemens AG Medical Solutions (2015) Summary page 4.

## Most influential descendants
- K203258: syngo.CT Lung CAD (2021), 4 descendants of its own
- K221592: AVIEW Lung Nodule CAD (2023), 2 descendants of its own
- K251203: AVIEW Lung Nodule CAD (2025), 0 descendants of its own
- K242919: V5med Lung AI (2025), 0 descendants of its own
- K231157: syngo.CT Lung CAD (Version VD30) (2023), 0 descendants of its own

## Indications for use
The syngo.CT Lung CAD VC30 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 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/K193216
Methodology: https://510kreport.com/methodology