KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0

K043104 · Practiceworks, Inc. · EHD · Feb 24, 2005 · Dental

Device Facts

• Record ID: K043104
• Device Name: KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
• Applicant: Practiceworks, Inc.
• Product Code: EHD · Dental
• Decision Date: Feb 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Software platform for orthodontic/oral surgery practices; runs on Windows PC in peer-to-peer network. Inputs: digital photographs, x-rays, electronic models; retrieves images from external imaging systems. Functions: storage, organization, annotation, printing; optional modules for cephalometric tracing, measurement analysis, and orthodontic/surgical treatment simulation. Integrates with Kodak practice management systems or operates standalone. Does not natively control x-ray hardware but provides interface to access Kodak 8000/8000C control panels. Clinicians use display to visualize anatomical structures, maintain patient records, and plan treatments. Output: digital image displays, cephalometric analyses, treatment simulations. Benefits: centralized digital record-keeping, standardized diagnostic analysis, and improved treatment planning.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Software-based image processing system; Windows PC platform; peer-to-peer network architecture. Features modular design (base system, analysis module, planner module). Integrates with practice management software and external radiographic hardware via interface.

Indications for Use

Indicated for use by orthodontists, oral surgeons, and clinical staff for storing and organizing dental images (digital photos, x-rays, electronic models). Includes cephalometric tracing, measurement analysis, and growth/surgical prediction capabilities.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Chairside (K982422)
• DentalEye (K012439)

Reference Devices

• TrophyPan (K023346)
• TrophyPan C (K033690)
• Kodak 8000
• Kodak 8000C

Submission Summary (Full Text)

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Kodak Orthodontic Imaging 8.0 and OMS Imaging 8.0 Software

PracticeWork LLC. A subsidiary of Eastman Kodak Company

# FEB 2 4 7005510(k) Summary Kodak Orthodontic and OMS Imaging 8.0 software

# 1. Company Identification

Practiceworks, LLC, a subsidiary of Eastman Kodak Company 1765 The Exchange Atlanta, GA 30339 Establishment Registration: Pending Owner/Operator Registration: 1315356

### 2. Contact Person

Dan Hoefer Manager, Regulatory Affairs Kodak Dental Systems

#### 3. Device Name

Kodak Orthodontic Imaging 8.0, Kodak OMS Imaging 8.0 Commercial name: Orthodontic and Oral Surgery Imaging Software Common name: System, Image Processing, Radiological Classification name:

## 4. Device Classification

II Class: Product Code: LLZ

#### 5. 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.

#### 6. 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.

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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.

# 7. Substantial Equivalence

Kodak Orthodontic and OMS Imaging 8.0 is substantially equivalent to Chairside (K982422, EagleSoft) and DentalEye (K012439, Radco Data AB).

- Each device is indicated for use in dental or dental sub-specialty . diagnostic image storage, editing, communication, manipulation and viewing.
- The technological characteristics and principles of operation are . equivalent, as each device is software that operates on a Windows-based PC platform.
- The intended users of each device are the same or similar. .
- The devices are equivalent in terms of energy used or delivered, materials, . biocompatibility, standards, and other applicable characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K043104

FEB 2 4 2005

Trade/Device Name: Kodak Orthodontic Imaging and OMS Imaging Version 8.0 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: January 21, 2005 Received: January 24, 2005

Dear Mr. Hoefer:

Mr. Daniel Hoefer

Kodak Dental System

Practice Works, Inc.

1765 The Exchange

ATLANTA GA 30339

Manager, Regulatory Affairs

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levicwed your becasil b re(x) peopleantially equivalent (for the indications for use stated in above and nave determined the ad predicate devices marketed in interstate commerce prior to the chelosure) to regally maneled production Device Amendments, or to devices that have been May 26, 1770, the chacinent acts of the Federal Food, Drug, and Cosmetic Act (Act) that reciassified in accondation while proval application (PMA). You may, therefore, market the do not require approval of a promance approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (600 as 10) alitional controls. Existing major regulations affecting your Apploval), it thay oc subject to Jack aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA uce vice can of round in the eneming your device in the Federal Register.

Please be adviscd that FDA's issuance of a substantial equivalence determination does not mean that FICA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I cut at statues and regulations assnot limited to registration and listing (21 CFR Part 807); labeling Act STEQuirements, mediating practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneling of substantial equivalence of your device to a legally premarket nothreation: "The I DA miding of backannal vice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your derros on the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "formation on your responsibilities under the Act from the 807.77). Tou may obtain other general and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Kodak OrthoImaging 8.0 software is indicated for use by orthodontists and their Kodak Orinothiaging 6.0 sortware in minutes rocluding digital photographs and xclinical staff in storing and organizing images, including digital photograph clinical staff in storing and organizatify interests arenally cephalometric radiograph,
rays. The device includes the capability to trace a digital crapications rays. The device mendes the capactive of anywords or surgical predictions.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter

Daniel H. Lyman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043104