# K022692: Voxelplus Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Mevisys Co., Ltd.
- Decided: Oct 11, 2002 after 59 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
Longest line of descent: 3 generations back to K954678 (1996). 3 ancestors in all.
252 later devices descend from it; 4 cite it directly.
1 of 256 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 1.

## Most influential descendants
- K051528: Mevis Liveranalyser/Liverviewer Software (2005), 226 descendants of its own
- K061696: Iqqa-Liver Software (2006), 217 descendants of its own
- K071310: Syngo CT Oncology Software Package (2007), 195 descendants of its own
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own

## Indications for use
The VoxelPlusTMis a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K022692
Methodology: https://510kreport.com/methodology