# K043194: Voxar 3D Product Family

- Pathway: 510(k) (Traditional)
- Applicant: Voxar Limited
- Decided: Jan 11, 2005 after 54 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 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
- K132853: Novapacs (2014), 6 descendants of its own
- K160371: NovaPACS (2016), 5 descendants of its own
- K171754: NovaPACS (2017), 4 descendants of its own
- K231662: Aid-U (2024), 1 descendant of its own
- K221796: Cyware 4H and Cysart 4H (2022), 1 descendant of its own

## Indications for use
The Voxar 3D product family is a suite of products thct is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpretin9 DICOM comp!iant tomogiaphic 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 (mpr's), oblique mpr's, curved / cross - curved MPR's, slab MPR's AvelP, MIP, MiniP, measurements, annotations, reporting, distribution, etc * Tools for in depth analysis, such as segmentation, enescopic review, colour VR slab, 3D volume review, path definition and boundary detection, PET imagery analysis, etc * Specialist tools and workflow enhancements for specific clinical applications which provide targeted workflows, custom UI, targeted measurement and reporting functions including colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), calcium scoring (which is intended for non - invasive identification and quantification of calcifieatherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms), Vessel analysis (which is intended for the qualative and quantative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc

Source page: https://510kreport.com/device/K043194
Methodology: https://510kreport.com/methodology