# K013381: Advanced Lung Analysis-1

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Oct 26, 2001 after 14 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: 2 generations back to K913770 (1991). 2 ancestors in all.
470 later devices descend from it; 7 cite it directly.
1 of 473 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963345: Advantage Windows Tissue Volume Option, GE Medical Systems (1996) Summary page 1.

## Most influential descendants
- K022013: Lungcare CT Software Package (2002), 379 descendants of its own
- K033374: Lungcare CT Software Package with Extended Functionality (2003), 295 descendants of its own
- K063762: Syngo Circulation Software Package with Extended Functionality (2007), 263 descendants of its own
- K041484: Undecided (2004), 222 descendants of its own
- K053301: Cedara I-Response Cedara Pet/CT (2006), 221 descendants of its own

## Indications for use
Advanced Lung Analysis (ALA-I) 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 analysis is performed on the Advantage Windows Workstation (K913770). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. This may aid the physician in characterization of suspicious nodules and thus, patient management care decision process.

Source page: https://510kreport.com/device/K013381
Methodology: https://510kreport.com/methodology