# K193293: XV Lung Ventilation Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: 4Dx Limited
- Decided: May 14, 2020 after 169 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: 11 generations back to K801623 (1980). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 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.
- K181407: Artis zee/zeego & Artis Q/Q.zen, Siemens Medical Solution USA, Inc. (2018) Summary page 4.

## Indications for use
The XV Ventilation Lung Analysis Software is software-based image processing technology that analyzes cinefluorograph images and a CT (can be a previously acquired CT that is representative of the patient’s present lung envelope), to quantify ventilation of pulmonary tissue for use in adult patients. The XV Ventilation Lung Analysis Software provides reproducible quantification of ventilation for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. For use by referral from a pulmonary specialist or equivalent, the Device can be used to provide the physician with additional clinical data in the diagnosis and documentation of inhomogeneities and defects in pulmonary ventilation. Quantification and statistics are provided in the form of a Report, including: • The tidal volume (i.e. total lung ventilation), presented as a single value; • Visualization of lung ventilation with color-defined specific ventilation ranges overlaid on the CT slices; • The heterogeneity of lung ventilation, presented as three values, which quantifies the regional variability of the ventilation; and • Ventilation graph/ histogram of the classified lung voxel’s relative frequencies showing the frequency distribution of regional specific ventilation measured across the entire lung, including ventilation defect percentage which shows the volume of lung with low ventilation. The clinical study used to validate the Device was limited to patients selected to undergo Radiation Therapy (most commonly for breast cancer and esophageal cancer). In this study these patients were examined using the Device at four time-points over a 13-month period (twice prior and twice following radiation therapy).

Source page: https://510kreport.com/device/K193293
Methodology: https://510kreport.com/methodology