# K023003: Imagechecker-CT Workstation

- Pathway: 510(k) (Traditional)
- Applicant: R2 Technology, Inc.
- Decided: Nov 20, 2002 after 72 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: 3 generations back to K913770 (1991). 6 ancestors in all.
177 later devices descend from it; 7 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011142: Aquarius Workstation, Terarecon,Inc. (2001)
- K973010: Realtime 3D Diagnostic Workstation, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K020483: Advantage Workstation 4.1, GE Medical Systems (2002) Summary page 1.

## Most influential descendants
- K032748: VITREA2, Version 3.4 Medical Image Processing Software (2003), 170 descendants of its own
- K040305: VITREA2 Version 3.5 (2004), 164 descendants of its own
- K043333: VITREA2, Version 3.7 Medical Image Processing System (2004), 143 descendants of its own
- K052632: VITREA2 Version 3.8 Medical Image Processing Software (2005), 117 descendants of its own
- K061624: Vitrea, Version 3.9 (2006), 111 descendants of its own

## Indications for use
The general indications for use of the Imagechecker-CT Workstation are as a general imaging workstation to assist radiologists in reviewing digital computed Tomography (CT) images of the chest. Specific indications for use for the Imagechecker-CT Workstation are the display of a composite view of 2D cross-sections, and 3D volumes of chest CT’ images, including findings or regions of interest (“ROI”) identified by the radiologist or Computer Assisted Detection (“CAD”) findings.

Source page: https://510kreport.com/device/K023003
Methodology: https://510kreport.com/methodology