# K151919: Vitrea CT Lung Density Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Oct 10, 2015 after 89 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.
10 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083227: Vida Pulmonary Workstation 2 (PW2), Vida Diagnostics, Inc. (2008) Summary page 4.

## Most influential descendants
- K171199: AVIEW (2018), 6 descendants of its own
- K200714: AVIEW (2020), 5 descendants of its own
- K214036: AVIEW (2022), 4 descendants of its own
- K233211: Aview Cac (2024), 2 descendants of its own
- K232392: CT Lung Ventilation Analysis Software (CT:V) (2023), 1 descendant of its own

## Indications for use
The Vitrea Lung Density Analysis software provides CT values for the pulmonary tissue from CT thoracic datasets. Three-dimensional (3D) segmentation of the left lung and right lung, volumetric analysis, density evaluations and reporting tools are integrated in a specific workflow to offer the physician a quantitative support for diagnosis and follow-up evaluation of lung tissue images.

Source page: https://510kreport.com/device/K151919
Methodology: https://510kreport.com/methodology