# K151283: Lung Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Oct 30, 2015 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: 7 generations back to K913770 (1991). 23 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043333: VITREA2, Version 3.7 Medical Image Processing System, Vital Images, Inc. (2004) Summary page 5.

## Most influential descendants
- K162484: Lung Nodule Assessment and Comparison Option (LNA) (2017), 7 descendants of its own
- K202990: NinesMeasure (2021), 1 descendant of its own
- K193220: Aview LCS (2020), 1 descendant of its own
- K240554: InferRead Lung CT.AI (2025), 0 descendants of its own
- K240740: qCT LN Quant (2024), 0 descendants of its own

## Indications for use
The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.

Source page: https://510kreport.com/device/K151283
Methodology: https://510kreport.com/methodology