# K040028: CA-1500

- Pathway: 510(k) (Traditional)
- Applicant: R2 Technology, Inc.
- Decided: Jan 22, 2004 after 14 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 4 generations back to K913770 (1991). 10 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023003: Imagechecker-CT Workstation, R2 Technology, Inc. (2002) Summary page 1.
- K013381: Advanced Lung Analysis-1, General Electric Co. (2001) Summary page 1.
- K022013: Lungcare CT Software Package, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.

## Most influential descendants
- K060378: VITREA2 Version 3.8.1 (2006), 1 descendant of its own
- K201501: Veolity (2021), 0 descendants of its own
- K120161: Alphapoint Imaging Software (2012), 0 descendants of its own
- K070868: LMS-Lung/Track (2007), 0 descendants of its own

## Indications for use
The Comprehensive Chest Analysis Tools (C-CAT) package consists of software that enables radiologists to view, analyze, register and compare new and previous series of thoracic CT images. The software package assists the radiologists by calculating volume change and doubling time of selected segmented candidate thoracic abnormalities, such as pulmonary and pleural nodules and lesions, found on these images. The software is designed to assist the radiologists in characterization and classification of these suspicious candidate thoracic abnormalities in terms of size, dimension, shape and position and thus aid in the patient management care decision process.

Source page: https://510kreport.com/device/K040028
Methodology: https://510kreport.com/methodology