# K113715: Lung Volume Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Aug 17, 2012 after 242 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: 6 generations back to K954355 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071513: Inspace 4D Software Package with Extended Functionality, Siemens Medical Solutions (2007) Summary page 1.

## Indications for use
The Lung Volume Analysis can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D3 segmentation & isolation of subcompartments, volumetric analysis) and reporting tools are combined with a dedicated workflow. This software application can be Used with standard non-contrast-enhanced chest volume acquisitions. When used by a qualified physician, a potential application is to determine the course of treatment.

Source page: https://510kreport.com/device/K113715
Methodology: https://510kreport.com/methodology