# K012072: Voxar VC, Model 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Voxar Limited
- Decided: Jul 12, 2001 after 10 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.
219 later devices descend from it; 3 cite it directly.
1 of 220 devices in its family (counting itself) has 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
- K033102: Medic Colon Model, Release 1 (2003), 210 descendants of its own
- K042674: Colon Car 1.2 (2004), 209 descendants of its own
- K061214: Aquariusaps Server (2006), 134 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K083423: Coloncad Api 3.1 (2011), 70 descendants of its own

## Indications for use
Voxar Colonscreen is a software application for the display and 3D visualization of medical image data derived from CT and MR scans for the purpose of assisting in patient review and detection of colon polyps, cancers and other lesions by providing display and reporting facilities to enhance workflow. It is intended for use by radiologists, clinicians and referring physicians to process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.

Source page: https://510kreport.com/device/K012072
Methodology: https://510kreport.com/methodology