DENTAL DIGITAL X-RAY IMAGING SYSTEM

K073365 · VATECH Co., Ltd. · MUH · Apr 8, 2008 · Dental

Device Facts

• Record ID: K073365
• Device Name: DENTAL DIGITAL X-RAY IMAGING SYSTEM
• Applicant: VATECH Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Apr 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Vatech system is intended as an extraoral digital xray system that allows for panoramic tomographic imaging and teleradiography. It essentially has the same use as the predicate devices for X-ray computed tomography of the head and neck for dental, oral, and related medical use imaging.

Device Story

Digital panoramic dental imaging system; utilizes high-resolution CCD detector for real-time digital image acquisition. Captures X-ray projections of skull, dentition, and oral structures. Operated by physicians, dentists, or X-ray technologists in clinical settings. System features rotating image capability and chin rest positioning for patient alignment. Produces high-quality digital images for diagnostic review by healthcare providers. Benefits include lower radiation dose compared to traditional methods and simplified user interface for efficient workflow.

Clinical Evidence

Bench testing only. The device was developed and validated according to applicable standards. Risk analysis and safety certifications indicate no new safety issues compared to predicate devices.

Technological Characteristics

Extraoral digital X-ray system; utilizes high-resolution CCD detector for image acquisition. Employs Toshiba high-voltage X-ray tubes. Features rotating image capability and chin rest positioning. System is designed for panoramic tomographic imaging and teleradiography.

Indications for Use

Indicated for producing diagnostic x-ray radiographic images of skull, dentition, and oral structures. Intended for use by physicians, dentists, and x-ray technologists.

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

• Sinora Dental Systems Digital Xray System Model Orthophos 3/3 Ceph/3DS (K990528)
• Intrumentarium Corp. Digital Xray System Model Orthoceph OC100D (K001439)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(K) SUMMARY February 15, 2008 K073365

APR - 8 2008

#### SUBMITTER INFORMATION:

Vatech Co., Ltd. 75-11 Seogu-ri, Dongtan Myeon Hwaseong-si, Gyeonggi-do 445-811 Korea

#### APPLICANT/FDA AGENT/CORRESPONDING OFFICIAL INFORMATION:

North American Technical Services (NATS) Corp 30 Northport Rd Sound Beach, NY 11789 Tel: [phone] Fax: [phone] Email: [e-mail] Contact: Stephen T. Mlcoch

#### DEVICE NAME:

Name: Digital X-Ray Imaging System Proprietary Model: PaX-P&P Classification: System, Xray Extraoral Source Digital (code MUH) Class 2 - 872.1800

#### PREDICATE DEVICES:

Sinora Dental Systems Digital Xray System Model Orthophos 3/3 Ceph/3DS - K990528 Intrumentarium Corp. Digital Xray System Model Orthoceph OC100D - K001439

#### DESCRIPTION:

Vatech Model PaX-P&P is a digital panoramic dental imaging system. It uses high resolution CCD detector for real time digital image acquisition. It has lower radiation dose results, simple user interface and high quality producing capability.

#### INTENDED USE:

The Vatech system is intended as an extraoral digital xray system that allows for panoramic tomographic imaging and teleradiography. It essentially has the same use as the predicate devices for X-ray computed tomography of the head and neck for dental, oral, and related medical use imaging.

{1}------------------------------------------------

## COMPARISON TO PREDICATE DEVICES:

The Vatech system has the same use and capability as both of the predicate devices named. The Vatech and Instrumentarium high voltage tubes are from the same Toshiba tube family and have the same fundamental electronic design. The CCD, radiographic, extraoral sensing and imaging methods are all similar characteristics used by these systems. They all have rotating image capability and similar chin rest positioning.

Small differences in methodology, technique, and cosmetic appearance offer no new concerns regarding safety and effectiveness. The Vatech system is technologically equivalent in concept, function and performance to the predicate devices.

#### CONCLUSION:

The Vatech model PaX-P&P has been developed and validated according to all applicable standards. Evaluations have proven that the system is safe and effective for the intended use. Risk analysis and safety certifications reveal that there are no new safety issues associated with this system as compared with the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an abstract symbol, which is the main element of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR - 8 2008

Vatech Co., Ltd. c/o Mr. Stephen T. Mlcoch North American Technical Services Corporation 30 Northport Road SOUND BEACH NY 11789

Re: K073365

Trade/Device Name: Vatech Co., Ltd. Digital X-ray Imaging System Model PaX-P&P Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory class: II Product Code: MUH Dated: February 18, 2008

Received: March 5, 2008

Dear Mr. Mlcoch:

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.

{3}------------------------------------------------

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 Ant 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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

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

{4}------------------------------------------------

Vatech Co., Ltd. Digital X-ray Imaging System Model PaX-P&P 510K Notification

#### INDICATIONS FOR USE

513(k) Number (if known):

Device Name:

Vatech Co., Ltd. Digital X-ray Imaging System Model PaX-P&P

Incications for Use:

PaX-P&P is a digital x-ray system that uses a high resolution CCD detector for real time digital image acquisition. The system allows lower radiation dose, simple user interface, and produces high quality images. It is intended for producing diagnostic x-ray radiographic images of skull, dentition, and oral structures. The device is operated and used by physicians, dentists, and x-ray technologists.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

==============================================================================================================================================================================

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Nancy C. Brogdon

.

(Division Division of Reproductive, Abdominal an Radiological Devices 510(k) Number