# K081347: Iluma Vision

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: May 28, 2008 after 14 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 2 cite it directly.
0 of 27 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
- K123519: Invivo  Dental (2013), 24 descendants of its own
- K140713: Planmeca Romexis (2014), 14 descendants of its own
- K162799: Cliniview (2017), 13 descendants of its own
- K203156: DTX Studio Clinic (2020), 10 descendants of its own
- K213562: DTX Studio Clinic 3.0 (2022), 9 descendants of its own

## Recalls of this device
- Aug 3, 2009 · Not classified · Z-2239-2009: Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.

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

Source page: https://510kreport.com/device/K081347
Methodology: https://510kreport.com/methodology