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510(k) Data Aggregation
K Number
K043104Device Name
KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
Manufacturer
PRACTICEWORKS, INC.
Date Cleared
2005-02-24
(107 days)
Product Code
EHD, LLZ
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
PRACTICEWORKS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Kodak Orthodontic and OMS Imaging 8.0 software is intended for use by orthodontists, oral surgeons and their clinical staffs in storing and organizing images, including digital photographs, x-rays, electronic models, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken and make growth or surgical predictions.
Kodak OrthoImaging 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.
Device Description
Kodak Orthodontic and OMS Imaging 8.0 software is designed for installation on an off-the-shelf PC running Microsoft Windows in a peer-to-peer network. Identical software is to be supplied to both orthodontic (commercial name: Orthodontic Imaging 8.0) and oral surgery (commercial name: OMS Imaging 8.0) markets.
The software consists of patient management software for orthodontic, and oral surgery practices. It provides the ability to connect satellite offices and will be marketed as a base system, with additional modules offered as options. The base system will include the storage, annotation and printing of images. The optional analysis module will allow the user to trace the cephalometric x-rays using standard analyses. The optional planner module will allow the user to simulate orthodontic or surgical treatment.
When the system is used with the TrophyPan or TrophyPan C panoramic and cephalometric x-ray systems (K023346, K033690, now marketed as Kodak 8000 and 8000C) the practitioner can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data. The software does not natively control any x-ray device, but instead provides the user an interface by which he may access the control panels available with the Kodak 8000/8000C x-ray systems.
Kodak Orthodontic and OMS Imaging 8.0 software includes programming that enables the user to retrieve an electronic copy of an x-ray image from other imaging systems.
The imaging software can be integrated with Kodak practice management system software or used as a stand-alone product.
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