# K024149: Primelung

- Pathway: 510(k) (Traditional)
- Applicant: Accuimage Diagnostics Corp.
- Decided: Feb 21, 2003 after 67 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: 4 generations back to K945188 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022013: Lungcare CT Software Package, Siemens Medical Solutions USA, Inc. (2002)
- K013381: Advanced Lung Analysis-1, General Electric Co. (2001)
- K990241: Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt, and Accumip, Accuimage Diagnostics Corp. (1999) Summary page 1.

## Most influential descendants
- K070868: LMS-Lung/Track (2007), 0 descendants of its own

## Indications for use
Comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the reading physician to analyze regions of the lung, such as nodules and other lung parameters, and to generate an automatic report.

Source page: https://510kreport.com/device/K024149
Methodology: https://510kreport.com/methodology