KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM

K971894 · Eastman Kodak Company · LMA · Aug 20, 1997 · Radiology

Device Facts

• Record ID: K971894
• Device Name: KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
• Applicant: Eastman Kodak Company
• Product Code: LMA · Radiology
• Decision Date: Aug 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The KODAK DIGITAL SCIENCE Dental Scanning System is designed to interface with practice management software. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KODAK DIGITAL SCIENCE Dental Scanning System is designed to interface with practice management software. Intended uses in the dental industry include the following: - . Scanning of film

Device Story

System converts dental X-ray film to digital images; utilizes flatbed scanner with transparency adapter; connects to PC via SCSI interface. TWAIN Data Source software controls scanner; applies tone scaling and proprietary enhancement algorithms to optimize images. Used in dental clinics by practitioners; facilitates consultations, electronic archiving, and integration with practice management systems. Healthcare providers view digitized images on monitors; enhanced clarity supports diagnostic decision-making for dental pathologies. Benefits include faster image recall, efficient study assembly, and improved remote consultation capabilities.

Clinical Evidence

Bench testing only. Comparison of functional equivalence and image quality/enhancement test results provided to demonstrate performance comparable to predicate devices.

Technological Characteristics

36-bit 600 dpi flatbed scanner with transparency adapter; SCSI interface to PC. Software-based image processing using tone scaling and proprietary enhancement algorithms. TWAIN interface for practice management system integration. Operates on standard PC-compatible hardware.

Indications for Use

Indicated for scanning dental radiographic film. Patient population includes the general public for diagnosis of dental caries, periodontal disease, bone loss, tooth fractures, jaw misalignment, and other dental conditions encountered by general practitioners and specialists.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Kodak Digital Science Film Digitizer L7501/L7506 (K961768)
• TAU Corporation TigerScan/TigerView (K955237)

Submission Summary (Full Text)

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#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# I. Date Prepared:

AUG 20 1997

(

April 13, 1997

#### II. Submitter:

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

#### ill. Contact Person:

Judith A. Wallace Regulatory Affairs [phone]

#### IV. Device Name:

Kodak Digital Science Dental Scanning System Trade Name

Dental x-ray scanning and 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:

Kodak Digital Science Film Digitizer L7501/L7506 -- 510(k) No. K961768 TAU Corporation TigerScan/TigerView -- 510(k) No. K955237

# VII. Description of Device:

The KODAK DIGITAL SCIENCE™ Dental Scanning System consists of the KODAK Image Magic TM Print Scanner 2000, a transparency adapter, and TWAIN Data Source software. The KODAK Image Magic™ Print Scanner 2000 is a 36 bit 600 dpi flatbed scanner connected to the user's computer through a SCSI interface. The transparency adapter provides an overhead light source for transparent media. The TWAIN Data Source software is used to control the scanner, optimize the scanned image using tone scaling algorithms, and communicate with application software through the TWAIN interface.

Kodak's Dental X-ray Scanner (KODAK DIGITAL SCIENCE™ Dental Scanning System or KDS DSS) is designed to support; dental radiography scanning to convert film

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to digital form. The KDS DSS is designed to operate on a standard PC-compatible computer and accomplish scanning with a commercially available quality flatbed scanner interfaced to the PC.

The KDS Dental Scanning System is a fully functional digital radiograph scanning system. Features include; advanced graphical user interface, intelligent scanning and image enhancement, scanning of full-mouth sets and other mounts, and interfaces to practice management systems.

#### VIII. Indications for Use:

The KODAK DIGITAL SCIENCE Dental Scanning System is designed to interface with practice management software. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KODAK DIGITAL SCIENCE Dental Scanning System is designed to interface with practice management software.

Intended uses in the dental industry include the following:

- . Scanning of film
? # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # #

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 Scanning System is substantially similar to the TAU Corporation TigerScan/TigerView system (K955237), the KODAK DIGITAL SCIENCE Film Digitizer L7501/L7506 (K961768) as well as numerous other x-ray digitizers currently on the market. The basis for the equivalence is that both systems consist of a flatbed scanning device interfacing with a personal computer which digitizes dental x-ray film with image preview software containing similar functionality. The following table summarizes the three products functional equivalence.

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| Product Functional Equivalence Comparison | | | |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------|--------------------------------------------|----------------------------------------|
| Function | KODAK DIGITAL<br>SCIENCE<br>Dental Scanning<br>System | KODAK DIGITAL<br>SCIENCE<br>Film Digitizer | TAU<br>TigerScan/TigerView |
| Conversion of<br>film to digital<br>image | Commercial Flatbed<br>Scanner with TPU | Commercial Flatbed<br>Scanner with TPU | Commercial Flatbed<br>Scanner with TPU |
| Control of<br>scanner, storage,<br>retrieval,<br>transmission, and<br>receipt of digital<br>images | Personal Computer | Personal Computer | Personal Computer |
| Mouse,<br>windows, menus,<br>etc. Used to<br>control device | Graphical User<br>Interface (GUI) | Graphical User<br>Interface (GUI) | Graphical User<br>Interface (GUI) |
| Image display<br>and optimization | Image Processing | Image Processing | Image Processing |
| Integrate with<br>practice<br>management<br>systems | TWAIN Interface | TWAIN Interface | Proprietary API |

Each system performs high definition scanning of images from dental x-ray film for display on monitors. Based on input quality the level of clarity and definition is similar, although the KODAK DIGITAL SCIENCE Dental Scanning System has the ability with its proprietary enhancement algorithms to image enhance.

The only real difference in the systems is the choice of hardware, interface connection options and the ability to enhance poor quality images. Both systems use reliable, mature components. The software and system functionalities are comparable with few minor exceptions in image enhancement ( refer to image quality/enhancement test results).

Based on the similarities of the purpose and functionalities of these three systems, Kodak concludes that the KODAK DIGITAL SCIENCE Dental Scanning System is substantially equivalent to the TAU Corporation TigerScan/TigerView x-ray scanning and imaging device and the KODAK DIGITAL SCIENCE Film Digitizer.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 20 1997

Judith A. Wallace Regulatory Affairs Associate Eastman Kodak Company 901 Elmgrove Road Rochester, NY 14653-5517

Re:

K971894 Kodak Digital Science - Dental Scanning System Dated: May 16, 1997 Received: May 22, 1997 Regulatory class: Unclassified Procode: 90 LMA

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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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" (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/cdr/h/dsmamain html".

Sincercly yours

h. William Yin

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

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# FACSIMILE OF CDRH'S "INDICATIONS FOR USE" PAGE

510(K) Number (if known): K971894 Device Name: KODAK DIGITAL SCIENCE - Dental Scanning System Indication of use: Scanning of dental radiographic film

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter

Yhril A. Benson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic

KODAK DIGITAL SCIENCE - Dental Scanning System 510(k) Number 510(k) Submission

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