# K012439: Dentaleye 2 Dental Image Management System

- Pathway: 510(k) (Traditional)
- Applicant: Radco Data AB
- Decided: Feb 6, 2002 after 190 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: 2 generations back to K930527 (1993). 2 ancestors in all.
63 later devices descend from it; 4 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955237: Tigerscan/Tigerview, Tau Corp. (1996) Summary page 1.

## Most influential descendants
- K050744: Kavo Ergocom/Ergocam (2005), 36 descendants of its own
- K060178: Vix Win Pro (2006), 35 descendants of its own
- K043104: Kodak Orthodontic Imaging and Oms Imaging 8.0 (2005), 25 descendants of its own
- K122427: CS Orthodontic Imaging Software CS Oms Imaging Software (2012), 22 descendants of its own
- K131570: Orthovision (2013), 19 descendants of its own

## Indications for use
Intended Uses for DentalEye 2 in the dental industry are as follows Acquiring and handling of dental radiographs and color images Viewing and manipulation for insurance claims adjudication Viewing and manipulation for diagnostic purposes Viewing for patient education and consultation including cosmetic imaging.

Source page: https://510kreport.com/device/K012439
Methodology: https://510kreport.com/methodology