# K050033: Lucion

- Pathway: 510(k) (Traditional)
- Applicant: Mevisys Co., Ltd.
- Decided: Feb 11, 2005 after 35 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: 4 generations back to K945512 (1995). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022692: Voxelplus Pacs, Mevisys Co., Ltd. (2002) Summary page 1.
- K020929: Smartscore 3.5; Smartscore 4.0; Smartscore 4.5, GE Medical Systems (2002) Summary page 1.

## Most influential descendants
- K062164: Resolutionmd, Version 1.3 (2006), 2 descendants of its own
- K100236: Stair Systems Pacs & Dicom Viewer (2010), 1 descendant of its own
- K112008: Touchpacs Suite (2012), 0 descendants of its own

## Indications for use
The Lucion TM is a software application 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/K050033
Methodology: https://510kreport.com/methodology