# K232392: CT Lung Ventilation Analysis Software (CT:V)

- Pathway: 510(k) (Traditional)
- Applicant: 4Dmedical Limited
- Decided: Nov 16, 2023 after 99 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: 8 generations back to K954355 (1995). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151919: Vitrea CT Lung Density Analysis Software, Vital Images, Inc. (2015) Summary page 4.

## Most influential descendants
- K251484: CT:VQ (2025), 0 descendants of its own

## Indications for use
CT: V software is a non-invasive image processing technology that measures volume changes from paired inspiration-expiration CTs to quantify and visualize regional and global ventilation. These regional measures are derived entirely from the lung tissue displacement and lung volume change between the paired inspiration-expiration chest CTs. CT: V is for use in adult patients. Quantification and visualizations are provided in the form of a report. CT: V may be used when physicians need a better understanding of a patient's lung function and/or respiratory condition.

Source page: https://510kreport.com/device/K232392
Methodology: https://510kreport.com/methodology