# K041380: Imagechecker-CT Software Package with Filling Defect Indicator

- Pathway: 510(k) (Traditional)
- Applicant: R2 Technology, Inc.
- Decided: Jun 8, 2004 after 14 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). 11 ancestors in all.
3 later devices descend from it; 2 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)
- K033374: Lungcare CT Software Package with Extended Functionality, Siemens AG Medical Solutions (2003) Summary page 1.
- K023003: Imagechecker-CT Workstation, R2 Technology, Inc. (2002) Summary page 1.

## Most influential descendants
- K060378: VITREA2 Version 3.8.1 (2006), 1 descendant of its own
- K120161: Alphapoint Imaging Software (2012), 0 descendants of its own
- K042408: Iqqa-Chest Software Package (2004), 0 descendants of its own

## Indications for use
The ImageChecker CT Software Package with Filling Defect Indicator (FDI) is used during the review of contrast-enhanced computed tomography (CT) images of the chest. This software tool enables the radiologist to view and analyze regions of the image containing low density within vascular structures that may be indicative of filling defects or other intravascular abnonualities. The software is designed to assist the radiologist in characterization and classification of these suspicious candidate thoracic abnonualities in tenus of density, size, dimension, shape and position, thus aiding in the patient management care decision process.

Source page: https://510kreport.com/device/K041380
Methodology: https://510kreport.com/methodology