# K082041: Fiatlux Visualize

- Pathway: 510(k) (Traditional)
- Applicant: Fiatlux Imaging, Inc.
- Decided: Aug 1, 2008 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: 7 generations back to K942120 (1994). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063470: Aycan Workstation Osirix, Aycan Digitalsysteme GmbH (2007) Summary page 1.
- K060505: Voxar 3D Enterprise, Model 6.1, Barcoview Mis Edinburgh (2006)

## Most influential descendants
- K090295: Bodyviz, Model 100 (2009), 0 descendants of its own

## Indications for use
FiatLux Visualize TM is a medical diagnosis software application that allows physicians, radiologists, medical technicians, nurses, and other trained medical professionals to select, review and analyze DICOM images acquired from CT and MR devices. It provides a suite of tools for 2D/3D reconstruction based on the input image dataset. FiatLux VisualizeTM software must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Mammographic and compressed images are not supported for viewing.

Source page: https://510kreport.com/device/K082041
Methodology: https://510kreport.com/methodology