TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY

K040556 · Eastman Kodak Company · EHD · Apr 7, 2004 · Dental

Device Facts

• Record ID: K040556
• Device Name: TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
• Applicant: Eastman Kodak Company
• Product Code: EHD · Dental
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The PracticeWorks TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists.

Device Story

System comprises extraoral dental panoramic/cephalometric X-ray hardware and Orthoimaging/OMS Imaging software accessory. Dentist acquires radiographic images of dentomaxillofacial region; images transmitted to computer display for visualization. Software enables electronic storage of images, hard/softcopy charts, treatment plans, clinical notes, and exam data. Facilitates record-keeping and clinical workflow in dental/orthodontic/oral surgery practices. Benefits include improved visualization of anatomical structures and centralized digital management of patient records.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extraoral source dental panoramic and cephalometric X-ray system. Includes software accessory for image archiving and management. Operates via computer display for visualization. Connectivity involves electronic storage in clinical software program.

Indications for Use

Indicated for dental patients requiring radiographic imaging of the dento-maxillo-facial area for diagnostic purposes. Used by dentists in dental, orthodontic, and oral surgery practices.

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.

Submission Summary (Full Text)

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I KUPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory

510(k) Summary
K040556

### 1. Company Identification

Eastman Kodak Company Health Imaging Group 343 State Street Rochester, NY 14650 Establishment Registration: 1317267

Practiceworks, Inc., an Eastman Kodak company 1765 The Exchange Atlanta, GA 30339 Establishment Registration: 1226003

## 2. Contact Person

Donald Ellis Director, Regulatory Affairs and Quality Systems

#### 3. Device Name

TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory

#### 4. Device Classification

Class II Product Code: EHD

#### 5. Intended Use

The PracticeWorks TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists.

#### 6. Device Description

The TROPHYPAN/TROPHYPAN C System is a panoramic extra-oral dental x-ray system, already marketed in the United States. Orthoimaging and OMS Imaging software consist of patient management software for dental, orthodontic, and oral surgery practices. By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory, the dentist 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

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hard and softcopy charts, treatment plans, clinical notes, and clinical exam data.

### 7. Substantial Equivalence

The modifications to the TROPHYPAN/TROPHYPAN C do not affect the materials, intended use, operating principles, or manufacture of the system as previously cleared. The indications for use and labeling have been modified but are substantially equivalent to the original device. The modification to the TrophyPand C consists of the addition of Orthoimaging/OMS Imaging software accessory for image archiving and management.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2004

Mr. Donald Ellis Director, Regulatory Affairs & Quality Systems Eastman Kodak Company 343 State Street ROCHESTER NY 14650

Re: K040556

Trade/Device Name: TrophyPan C with Orthoimaging/OMSimaging Accessory Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD

Dated: March 1, 2004 Received: March 17, 2004

Dear Mr. Ellis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA 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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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):

The PRACTICEWORKS, TROPHYPAN/TROPHYPAN C System with the Orthoimaging System accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists.

2040586

By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging System accessory, the dentist 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

## Concurrence of CDRH, Office of Device Evaluation

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter

Nancy Chogdon
(Division Sign-Off)

Division of Reproducti vé, Abdor and Radiological Devices 510(k) Number