# K061326: Voxar 3D Enterprise with Cardiametrix

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview Mis Edinburgh
- Decided: May 25, 2006 after 15 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.
25 later devices descend from it; 2 cite it directly.
0 of 26 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
- K103465: Synapse 3D Cardiac Tools (2011), 20 descendants of its own
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K171222: Vitrea Software Toshiba Package; VSTP-001A (2017), 12 descendants of its own
- K173088: Vitrea Software Toshiba Package VSTP-001A (2018), 11 descendants of its own
- K183013: Vitrea Software Package, VSTP-001A (2018), 9 descendants of its own

## Indications for use
The Voxar 3D product family Is a suite of products that Is Intended to provide toads for the reading and review of a DICOM compliant series of medical Images which can be Interpreted as representing a volume of data. These tools are meant for the use of trained medical Imaging professionals to aid in their reading and review of such data. The Voxar 3D product family provides several levels of functionality. Basic analysis tools used on B daily basis, such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs. AvelP, MIP, MinlP. measurements, annotatlons, reporting, and distibution. Tools for In-depth analysis, such as regional segmentation of anatomical structures within the Image data, endoscopic review. color volume rendering of finite thickness data cross-sections, 3D review of dae volumes, path definition through vascular and other tubular structures. boundary detection, and PET Image analysis. Specialist tools and worlflow enhancements for specific clinical applications which provide directed wordtlows, custom User Interfaces, and special measurement and reporting functions optimi'zed for the specific clinical applications. Also included are computer-aided detection algorithms which are designed to cue the user on possible structures of interest Specilized clinical applications Include: Colon Screening (which Is Intended for the screening of patents for colonic polyps, turnours and other lesions using tomographic Colonography), Vessel Analysis (which is Intended for the qualitative and quantitative analysis of tomographlc anglographic studies to evaluate occlusive and aneurismal diseases and the effectiveness of stents and stent grafts) Coronary artery analysis (which Is Intended for the qualitative and quantitative analysts of coronary arteries to evaluate-occlusive and aneurismal disease). Functional cardiac analysis (which Is intended to evaluate the functlonal characteristics of the heart).

Source page: https://510kreport.com/device/K061326
Methodology: https://510kreport.com/methodology