# K212494: Lung Image Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonx Corporation
- Decided: Sep 2, 2021 after 24 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.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173821: LungQ Software, Thirona Corporation (2018) Summary page 4.

## Indications for use
The Pulmonx LIA software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The LIA software can be used to support physician in the diagnosis and documentation of pulmonary tissue images (e.g. abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments (including lung structures), volumetric analysis, density evaluations, fissure evaluation, and reporting tools are provided.

Source page: https://510kreport.com/device/K212494
Methodology: https://510kreport.com/methodology