# K094064: Iluma Vision Model Version 2.2

- Pathway: 510(k) (Traditional)
- Applicant: 3M Imtec
- Decided: Apr 30, 2010 after 120 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: 1 generation back to K081347 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081347: Iluma Vision, Imtec Corp. (2008) Summary page 1.

## Indications for use
ILUMAVision is a software application used for the display and 3D visualization of medical image files from scanning devices, Such as CT, MRI, PET or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware. Additionally, lLUMAVision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. ILUMIAVision is not intended for use with mammography.

Source page: https://510kreport.com/device/K094064
Methodology: https://510kreport.com/methodology