# K042694: Advanced Lung Analysis II

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 18, 2004 after 49 days
- Product code: OEB (Lung Computed Tomography System, Computer-Aided Detection)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913770 (1991). 5 ancestors in all.
207 later devices descend from it; 3 cite it directly.
1 of 213 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013381: Advanced Lung Analysis-1, General Electric Co. (2001) Summary page 1.
- K033374: Lungcare CT Software Package with Extended Functionality, Siemens AG Medical Solutions (2003) Summary page 1.

## Most influential descendants
- K063324: Pet Vcar (2007), 204 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own

## Indications for use
Advanced Lung Analysis" is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA II software allows analysis and displays statistics for nodule characterization all the different nodule types. ALA II optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (8) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA II provides to physician with additional information, meant to complement diagnosis based on classical techniques.

Source page: https://510kreport.com/device/K042694
Methodology: https://510kreport.com/methodology