# K060505: Voxar 3D Enterprise, Model 6.1

- Pathway: 510(k) (Special)
- Applicant: Barcoview Mis Edinburgh
- Decided: Mar 29, 2006 after 30 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
No predicates in its family tree.
59 later devices descend from it; 4 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K072653: 3VISEON/Surgery (2008), 51 descendants of its own
- K120367: 3MENSIO Workstation (2012), 49 descendants of its own
- K153736: 3mensio Workstation (2016), 19 descendants of its own
- K141475: Endosize (2014), 16 descendants of its own
- K160376: EndoSize (2016), 13 descendants of its own

## Indications for use
The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging. The Voxar 3D product family provides several levels of functionality to the user * Basic analysis tools they use on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AveIP, MIP, MinIP, measurements, annotations, reporting, distribution, etc * Tools for in-depth analysis, such as segmentation, endoscopic review, colour VR slab, 3D volume review, path definition and boundary detection, PET imagery analysis, etc * Specialist tools and workdflow enhancements for specific clinical applications which provide targeted workflows, custom Ul, targeted measurement and reporting functions including Colon Screening (which is intended for the screening of patients for colonic polyps, turnours and other lesions using tomographic Colonography), Calcium Scoring (which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms), Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc-

Source page: https://510kreport.com/device/K060505
Methodology: https://510kreport.com/methodology