ANYRAY PORTABLE X-RAY SYSTEM

K081899 · E-Woo Technology Co., Ltd. · EHD · Aug 21, 2008 · Dental

Device Facts

• Record ID: K081899
• Device Name: ANYRAY PORTABLE X-RAY SYSTEM
• Applicant: E-Woo Technology Co., Ltd.
• Product Code: EHD · Dental
• Decision Date: Aug 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

AnyRay is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-fay source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Device Story

AnyRay is a wireless, handheld portable X-ray system; operates on 22.5V DC Lithium-Polymer battery. Integrates X-ray generator, controller, and beam-limiting device into a single handheld enclosure. Used by dentists and dental technicians in clinical settings to produce diagnostic X-ray images of teeth and jaws; utilizes intraoral image receptors. Operator selects exposure time via up-down buttons on the tubehead assembly; device generates high-voltage electricity to produce X-rays. Output is a diagnostic image captured on a receptor; assists clinicians in dental diagnosis. Includes optional chair for patient positioning. Benefits include portability and ease of use for extraoral imaging.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through performance testing against recognized standards including IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMI), IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32.

Technological Characteristics

Handheld X-ray system; 22.5V DC Lithium-Polymer battery power; 60kVp/2mA fixed output. Features circular scatter shield for radiation protection. Dimensions: 8.6"L x 6.0"H x 5.8"W; weight 5.3 lbs. Standards: IEC 60601-1, EN 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32. No direct/indirect patient contact materials.

Indications for Use

Indicated for use by trained dentists and technicians as an extraoral X-ray source for diagnostic imaging of teeth and jaws in adult and pediatric patients using intraoral image receptors.

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

• NOMAD Dental X-Ray System (K051795)

Submission Summary (Full Text)

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K081899

AUG 2 1 2008

## EXHIBIT 2 510(k) Summary

E-Woo Technology Co., Ltd. 1F/4F/5F, Yunmin Technotown, 473-4, Bora-Dong, Giheung-Gu, Yongin-Si, Gyeonggi-Do, Korea 446-904 Tel: [phone] Fax: [phone] Taewoo Kim, President & CEO January 15, 2008

1. Identification of the Device: Proprietary-Trade Name: Portable X-Ray System "AnyRay" Classification Name : Unit, X-Ray, Extraoral with Timer / Product Code EHD Common/Usual Name: Portable X-Ray System

2. Equivalent legally marketed device: This product is similar in design and identical in function to Portable Dental X-Ray System Model "NOMAD" (K051795, Aribex, Inc)

3. Indications for Use (intended use):

"AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-fay source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

4. Description of the device:

"AnyRay" is a wireless Portable X-Ray System that operates on DC22.5V supplied by a rechargeable Lithum-Polymer battery pack. The X-ray tubehead, X-ray controls and power source are ssembled into a single hand-held enclosure. The Package includes DC adaptor and Chair (Option) This equipment generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of xray generator, controller, beam limiting device and chair (Option). Operating principle is that x-ay generated by high voltage electricity into x-ray tube, which (Openatifs primelpes in this x-ray images on receptor.

| Feature | Predicate:<br>(NOMAD TM Dental X-Ray System, K051795) | New Device<br>Portable X-Ray System “AnyRay” |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Manufacturer | Aribex, Inc. | E-Woo Technology Co., Ltd. |
| Intended Use | Both systems are intended as extraoral x-ray sources to be used with intraoral image receptors<br>for diagnostic imaging by dentists or dental technicians. | |
| Body Size and<br>Weight | 13"L x 11.5H x 5.5"W/ 8.5lbs | 8.6"L x 6.0"H x 5.8"W/ 5.3lbs |
| Chair(Option)<br>and Weight | - | 18.8"L x 66.6"H x 27.0"W/76.1lbs |
| Source to skin<br>distance | 20cm | 20cm |
| | | |
| Cone diameter | 6cm | 6.5cm |
| User Interface | Up-down buttons for exposure time<br>selection, with timer display | Up-down buttons for exposure time<br>selection, with timer display |
| Backscatter<br>radiation<br>protection | 6.75" dia. Pb-filled acrylic plastic scatter<br>shield | Circular scatter shield |
| Exposure<br>switch | On tubehead assembly/control panel | On tubehead assembly/control panel |
| Tubehead<br>mounting | Handheld | Handheld |
| Energy Source | Rechargeable 14.4V DC NiCd battery pack | Rechargeable 22.5V DC Lithum-Polymer<br>battery pack. |
| Exposure Time | 0.01 – 0.99 seconds in 0.01 increments | 0.06 s ~ 2.0 s seconds in 0.01 increments |
| Time Accuracy | ± (10% + 1ms) | ± (10% + 1ms) |
| mA | 2.3mA Fixed | 2 mA(Fixed) |
| kVp | 60kVp Fixed | 60 kVp(Fixed) |
| Waveform | Constant Potential(DC) | Constant Potential(DC) |
| Duty Cycle | 1:60 | 1:60 |
| Electrical<br>Safety<br>Standards | IEC60601-1, UL60601-1, EN60601-1 | IEC60601-1, EN60601-1 |
| EMI Standards | IEC 60601-1-2 | IEC 60601-1-2 |
| Performance<br>Standard | 21 CFR 1020.30, 1020.31<br>IEC60601-1-3<br>IEC60601-2-7 | IEC60601-1-3, IEC60601-2-7<br>IEC60601-2-28, IEC60601-2-32 |
| Biocompatibility | - | Not applicable (No direct, indirect contact<br>with patient) |

- 5. Safety and Effectiveness, comparison to predicate device

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## 6. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification E-Woo Technology Co.,Ltd. concludes that the Portable X-Ray System "AnyRay" 's safety and effectiveness are substantially equivalent to predicate devices (NOMAD™ Dental X-Ray System (K051795, Aribex, Inc)) as described herein.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe. The figure is composed of three curved lines, and the globe is represented by a series of wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2008

E-Woo Technology Company, Ltd. % Mr. Tamas Borsai Responsible Third Party Official TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K081899

Trade/Device Name: "AnyRay" Portable X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: August 7, 2008 Received: August 11, 2008

Dear Mr. Borsai:

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.

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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.

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

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

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## Indications for Use

510(k) Number (if known) :

Device Name : Portable X-Ray System "AnyRay"

Indications For Use : "AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Prescription Use _ v (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)

Page 1 of 1

Agnih Whang
(Division Sign-Off)

nivision of Reproductive, Abdominal and Radiological Devices 510(k) Number

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