HDS INTRA-ORAL IMAGING SYSTEM

K042372 · Vatech Value Added Technology Co., Ltd. · MUH · Oct 4, 2004 · Dental

Device Facts

• Record ID: K042372
• Device Name: HDS INTRA-ORAL IMAGING SYSTEM
• Applicant: Vatech Value Added Technology Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Oct 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

Indicated for intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

Device Story

HDS Intra-oral Imaging System collects dental X-ray photons via sensor; converts to electronic impulses; transmits to image interface box via cable; connects to PC via USB 2.0. Used in dental clinics by dentists for diagnostic imaging. System includes sensor, interface box, and PC software. Output displayed on monitor for viewing and manipulation. Benefits include digital storage and diagnostic utility.

Clinical Evidence

Bench testing only. Software testing and validation performed according to internal protocols. No clinical data provided.

Technological Characteristics

Intra-oral digital X-ray sensor; USB 2.0 interface; 650,000 pixel matrix (688 x 944); 35 um pixel size; 14 lp/mm spatial resolution; 24.08 x 33.04 mm active area; 3.5 mm thickness. PC-based system.

Indications for Use

Indicated for dental patients requiring intra-oral X-ray imaging for diagnostic purposes by dentists.

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

• Suni Intraoral Imaging System (K021718)

Submission Summary (Full Text)

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K042372

## EXHIBIT 2 510(k) Summary VATECH

OCT 0 4 2004

Value Added Technology Co., Ltd. 75-11, Seokwoori, Dongtanmyun, Hwasungsi, Kyunggido, 445-811, Korea Tel: [phone] Fax: [phone] Chang Joon Ro, President & CEO July 29, 2004

- 1. Identification of the Device: Proprietary-Trade Name: "HDS" Intra-oral Imaging System Classification Name: Extraoral source x-ray system, Product Code 90 MUH Common/Usual Name: Intra-oral digital x-ray sensor
- 2. Equivalent legally marketed device: This product is similar in design and identical in function to the Suni Intraoral Imaging System (K021718, Suni Imaging Microsystems Inc.)
- 3. Indications for Use (intended use): Indicated for intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
- 4. Description of the device: The Intra-oral image system (HDS) is a device for digital intra oral X-rays imaging. It is fully USB compliant and can be plugged in any when computer is turned on.
- Intra-oral image system (HDS) block diagram
- PC
- · Image interface box (Read-out Box)
- · X-ray sensor

Image /page/0/Figure/12 description: The image shows a diagram of an X-ray sensor setup. The setup includes a computer with a display, an image interface box, a sensor cable, and a sensor. The computer is connected to the image interface box via a USB cable, and the image interface box is connected to the sensor via the sensor cable. The diagram labels each component of the setup.

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- 5. Safety and Effectiveness, comparison to predicate device:

| Feature | Predicate: Suni Intraoral Imaging<br>System (K021718) | Intraoral Imaging System<br>(HDS) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intra-oral Imaging System is<br>intended to collect dental x-ray<br>photons and convert them into<br>electronic impulses that may be<br>stored, viewed, and manipulated<br>for diagnostic use by dentists. | SAME |
| Computer interface | USB (USB version not specified) | SAME, Specification 2.0 |
| Pixel Matrix | 271,000, 462,000, 1.26 M, or 1.8<br>M pixels, depending on model | 650,000 pixels (688 × 944<br>pixel) |
| Pixel Size | 22.5 or 45 um (depending on<br>model) | 35 um |
| Active Area | 26.8 x 21.6 mm<br>32.7 x 20.6 mm<br>36.8 x 26.6 mm<br>36.8 x 26.6 mm | 24.08 mm x 33.04 mm |
| External Dimensions | 32.5 x 26.4 mm<br>37.8 x 24.7 mm<br>43.0 x 31.8 mm<br>43.0 x 31.8 mm<br>Thickness 3.2 mm | 29 × 41 mm<br>Thickness 3.5 mm |
| Spatial Resolution | 12 lp/mm (Standard res model) | 14 lp/mm |
| Applicable PC | Computer requirements not<br>specified. | -Software: Pentium 3,1 GHz<br>-Memory size: 128 MB<br>-Hard disk: 10GB<br>-VGA; 1024x768x24 bit<br>-Other: Window XP, Serial<br>USB port |

- 6. Testing information and Conclusion
In all material respects, the "HDS" Intra-oral Imaging System is substantially equivalent to Suni Intraoral Imaging System (K021718, Suni Imaging Microsystems Inc.) Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized bird or human figure with three horizontal lines extending from its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 4 - 2004

VATECH Value Added Tech., Co., Ltd. % Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates 'PO Box. 7007 DEERFIELD IL 60015

Re: K042372 Trade/Device Name: "HDS" Intra-Oral Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH

Dated: August 30, 2004 Received: September 13, 2004

Dear Mr. Kamm:

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 (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 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 premated 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 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 807.97). 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/dsma/dsmamain.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): K042372

"HDS" Intra-oral Imaging System Device Name:

Indications For Use: "HDS" Intra-oral Imaging System is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Syverson

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number .

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