# K123540: Syngo CT Pulmo 3D

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Aug 29, 2013 after 283 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: 7 generations back to K954355 (1995). 11 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071513: Inspace 4D Software Package with Extended Functionality, Siemens Medical Solutions (2007) Summary page 1.
- K083227: Vida Pulmonary Workstation 2 (PW2), Vida Diagnostics, Inc. (2008) Summary page 1.

## Most influential descendants
- K183271: AI-Rad Companion (Pulmonary) (2019), 6 descendants of its own
- K203699: syngo. CT Extended Functionalities (2021), 3 descendants of its own
- K213713: AI-Rad Companion (Pulmonary) (2022), 1 descendant of its own
- K220450: syngo.CT Applications (2022), 1 descendant of its own
- K214019: syngo.CT Extended Functionality (2022), 1 descendant of its own

## Indications for use
syngo.CT Pulmo 3D is an image analysis software for CT volume data sets. It analyses the lung, either completely or in parts, identifying areas with lower or higher Hounsfield values in comparison to a predefined threshold. These areas are evaluated using statistical methods such as histograms and percentiles. Using syngo.CT Pulmo 3D, you can examine the lung parenchyma and the airways of the lung. The following evaluation tools are provided: " Computation of lung volumes * Display of statistics related to the lung * Setting of markers * Airway measurements syngo.CT Pulmo 3D facilitates the reporting by using of appropriate reporting tools, for example, key image creation. You can use syngo.CT Pulmo 3D to create a DICOM Structured Report.

Source page: https://510kreport.com/device/K123540
Methodology: https://510kreport.com/methodology