KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER

K973476 · Eastman Kodak Company · EHD · Nov 10, 1997 · Dental

Device Facts

• Record ID: K973476
• Device Name: KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER
• Applicant: Eastman Kodak Company
• Product Code: EHD · Dental
• Decision Date: Nov 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Intended uses in the dental industry include the following: Radiograph viewing and manipulation for insurance claims adjudication. Radiograph viewing and manipulation for diagnostic purposes. Radiograph viewing for patient education and consultation. When used for diagnostic purposes, the patient population will be the general public, and the diseases/conditions that the device will be used to diagnose are; dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field.

Device Story

Software package for PC-compatible computers; enables display and manipulation of digitized dental x-ray images. Inputs: digitized dental radiographic film images. Processing: software-based image enhancement tools including rotation, zoom, flip, contrast, and brightness adjustment. Outputs: high-resolution images displayed on monitor for diagnostic review, insurance adjudication, and patient consultation. Used in dental clinics by general practitioners and specialists. Healthcare providers use output to visualize dental conditions; facilitates clinical decision-making regarding treatment planning and diagnosis. Benefits include improved image visualization and efficient practice management integration.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Software-based image viewer for PC-compatible computers (Pentium processor, 32MB RAM, Windows 95). Features high-resolution display (800x600, 24-bit color), image manipulation tools (rotate, zoom, flip, contrast, brightness), and monitor calibration. Interfaces with practice management systems. Standalone software application.

Indications for Use

Indicated for viewing and manipulation of dental radiographic film for insurance adjudication, diagnostic purposes, and patient education/consultation. Patient population: general public. Used by dental practitioners to diagnose dental caries, periodontal disease, bone loss, tooth fractures, and jaw misalignment.

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

• TAU Corporation TigerScan/TigerView (K955237)

Submission Summary (Full Text)

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NOV 1 1 1) 1697

. )

# 510(k) SUMMARY OF SAFETY AND EFFECTIVE NESS

#### I. Date Prepared:

September 12, 1997

## ll. Submitter:

Eastman Kodak Company Health Imaging Division Dental Business unit 343 State Street Rochester, New York 14650

## III. Contact Person:

Judith A. Wallace Regulatory Affairs [phone]

#### IV. Device Name:

Kodak Digital Science Dental Image Viewer Trade Name

Dental x-ray image enhancement system Common Name

## V. Device Classification:

FDA has classified the predicate device as Regulatory Class II under CFR 892.1750

## VI. Predicate Device:

TAU Corporation TigerScan/TigerView -- 510(k) No. K955237

## VII. Description of Device:

The KODAK DIGITAL SCIENCE™ Dental Image Viewer is a software package designed to provide full resolution digitized images of a dental x-ray film for diagnostic review, insurance adjudication and patient consultation. The KODAK DIGITAL SCIENCE™ Dental Image Viewer is designed to operate on a standard PC-compatible computer.

KODAK DIGITAL SCIENCE™ Dental Image Viewer features the display of full-mouth sets and other mounts, high-resolution image display and manipulation, and interfaces with practice management systems.

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# VIII. Indications for Use:

Intended uses in the dental industry include the following:

- Radiograph viewing and manipulation for insurance claims adjudication. .
- Radiograph viewing and manipulation for diagnostic purposes ●
- Radiograph viewing for patient education and consultation. .

When used for diagnostic purposes, the patient population will be the general public, and the diseases/conditions that the device will be used to diagnose are; dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field.

# IX. Substantial Equivalence:

The purpose and functionality of the KODAK DIGITAL SCIENCE™ Dental Image Viewer is substantially similar to the TAU Corporation TigerView system (K955237), as well as numerous other x-ray viewers currently on the market. The basis for the equivalence is that both systems consist of software which will enhance images for diagnosis. The following table summarizes the two products functional equivalence

| Description | Kodak Dental Image<br>Viewer | TAU TigerView |
|---------------------------------------|----------------------------------------------|-------------------------------------------------------------|
| Host Platform: | Pentium Processor based<br>Personal Computer | IBM - Compatible<br>Computer |
| Operating System: | Windows 95 | Windows 3.1. Windows for<br>Workgroups 3.11 or<br>Window 95 |
| Host RAM: | 32 MB | 16 MB |
| Host Magnetic Storage: | 10 MB | at least 400 MB |
| Host Floppy Drives: | 3.5 inches | 3.5 inches |
| Host Processor Speed: | Any Pentium speed | 486 66Mhz or better CPU |
| Host Monitor Size: | 15" diagonal minimum | |
| Display resolution | 800 X 600 at 24 bit color<br>minimum | 800 X 600 |
| Open Case Preview: | No | Yes |
| User Display Preferences: | Yes | No |
| Receive Images from other<br>Systems: | Yes | Yes |

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| Description | Kodak Dental Image<br>Viewer | TAU TigerView |
|--------------------------------------|---------------------------------------------|----------------------------------------------------------------|
| Patient List Transmission<br>Status: | No | Receiving status is<br>displayed. |
| Image Manipulation: | Rotate, Zoom, Flip,<br>Contrast, Brightness | Rotate, Zoom, Flip,<br>Contrast, Brightness,<br>Negative Image |
| Monitor Calibration: | Yes | |

KODAK DIGITAL SCIENCE - Dental Image Viewer 510(k) Submission

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 100 1997

Judith A. Wallace Regulatory Affairs Associate Eastman Kodak Company Health Imaging Division, Dental Business 343 State Street Rochester, NY 14650-1122

Re: K973476

Kodak Digital Science - Dental Image Viewer Dated: September 12, 1997 Received: September 15, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD

Dear Ms. Wallace:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

hJliau Yu
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):

Device Name: KODAK DIGITAL SCIENCE - Dental Image Viewer Indication of use: Viewing of dental radiographic film

Concurrence of CDRH, Office of Device Evaluation

| Prescription Use (Per 21 CFR 801.109) | <div> <span style="text-decoration: underline;">✓</span> </div> |
|---------------------------------------|-----------------------------------------------------------------|
| | OR |
| Over-The-Counter | <span style="text-decoration: underline;">____</span> |

KODAK DIGITAL SCIENCE - Dental Image Viewer
510(k) Submission

| (Division Sign-Off) | <div> <img alt="Signature" src="signature.png"/> </div> |
|--------------------------------------------------------------------|---------------------------------------------------------|
| | 9/12/97 |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973476 |