# K203258: syngo.CT Lung CAD

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Mar 31, 2021 after 146 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: 3 generations back to K063877 (2006). 3 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K193216: syngo.CT Lung CAD, Siemens Medi Cal Solutions, Inc. (2020) Summary page 5.

## Most influential descendants
- 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 device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid (part-solid and ground glass) pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked. The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as second reader after the radiologist has completed his/her initial read. The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface.

Source page: https://510kreport.com/device/K203258
Methodology: https://510kreport.com/methodology