# K141069: Lung Density Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Imbio, LLC
- Decided: Sep 17, 2014 after 146 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K070478: P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap), Straumann Manufacturing, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Imbio CT Lung Density Analysis Software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The Imbio CT Lung Density Analysis Software can be used to support the 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, volumetric analysis, density evaluations and reporting tools are provided.

Source page: https://510kreport.com/device/K141069
Methodology: https://510kreport.com/methodology