# K251484: CT:VQ

- Pathway: 510(k) (Traditional)
- Applicant: 4Dmedical Limited
- Decided: Aug 28, 2025 after 106 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: 9 generations back to K954355 (1995). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232392: CT Lung Ventilation Analysis Software (CT:V), 4Dmedical Limited (2023) Summary page 5.
- K090504: CSBP-001A Body Perfusion System, Toshibamedical Systems Corporation (2009) Summary page 6.

## Indications for use
CT:VQ software is a non-invasive image post-processing technology, using CT lung images to provide clinical decision support for thoracic disease diagnosis and management in adult patients. It utilizes two non-contrast chest CT studies to quantify and visualize ventilation and perfusion. Quantification and visualizations are provided as DICOM images. CT:VQ may be used when Radiologists, Pulmonologists, and/or Nuclear Medicine Physicians need a better understanding of a patient's lung function and/or respiratory condition.

Source page: https://510kreport.com/device/K251484
Methodology: https://510kreport.com/methodology