# K043104: Kodak Orthodontic Imaging and Oms Imaging 8.0

- Pathway: 510(k) (Traditional)
- Applicant: Practiceworks, Inc.
- Decided: Feb 24, 2005 after 107 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- 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 K930527 (1993). 4 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982422: Eaglesoft Chairside, Eaglesoft, A Patterson Co. (1998) Summary page 2.
- K012439: Dentaleye 2 Dental Image Management System, Radco Data AB (2002)

## Most influential descendants
- K122427: CS Orthodontic Imaging Software CS Oms Imaging Software (2012), 22 descendants of its own
- K131570: Orthovision (2013), 19 descendants of its own
- K173094: OrthoVision (2017), 18 descendants of its own
- K192888: EzOrtho (2020), 17 descendants of its own
- K210187: Overjet Dental Assist (2021), 6 descendants of its own

## Indications for use
Kodak Ortholmaging 8.0 software is indicated for use by orthodontists and their clinical staff in storing and organizing images, including digital photographs and x-rays. The device includes the capability to trace a digital cephalometric radiograph, analyze the measurements taken and make growth or surgical predictions.

Source page: https://510kreport.com/device/K043104
Methodology: https://510kreport.com/methodology