# K070831: Voxar 3D Enterprise with Colonmetrix and Pet/CT Perfusion

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview Mis Edinburgh
- Decided: May 22, 2007 after 57 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; 8 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
- K101662: Synapse 3D Basic Tools (2010), 14 descendants of its own
- K120361: Synapse 3D Base Tools (2012), 13 descendants of its own
- K203103: Synapse 3D, Synapse 3D Base Tools v6.1 (2021), 5 descendants of its own
- K221677: Synapse 3D Base Tools v6.6 (2022), 4 descendants of its own
- K151988: Visible Patient Suite (2015), 4 descendants of its own

## Indications for use
The Voxar 3D product family is a suite of products that is intended to provide tools 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 a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution. * 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 data volumes, path definition through vascular and other tubular structures and boundary detection. * Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows, custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Specialized clinical applications include: o Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), o Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurismal diseases and the effectiveness of stents and stent grafts) o Coronary Artery Analysis (which is intended for the qualitative and quantitative analysis of coronary arteries to evaluate occlusive and aneurismal disease), o Functional Cardiac Analysis (which is intended to evaluate the functional characteristics of the heart), o PET-CT Reading (which is intended for analysis of lesions using FDG imaging from hybrid PET-CT scanners) This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Source page: https://510kreport.com/device/K070831
Methodology: https://510kreport.com/methodology