MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR

K090526 · E-Woo Technology · MUH · Dec 2, 2009 · Dental

Device Facts

• Record ID: K090526
• Device Name: MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR
• Applicant: E-Woo Technology
• Product Code: MUH · Dental
• Decision Date: Dec 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The EzSensor is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

Device Story

EzSensor is a solid-state dental X-ray imager; replaces traditional film/screen systems. System components: X-ray sensor, image interface box, and PC. Sensor collects X-ray photons; converts to electronic impulses; transfers digital image to PC via USB 2.0 interface. Used in dental clinics by dentists for diagnostic imaging. Output viewed on PC display; allows storage and manipulation of images. Benefits include digital capture for dental radiographic applications.

Clinical Evidence

Bench testing only. Performance evaluated via electrical, mechanical, and environmental safety testing per EN/IEC 60601-1 and EMC testing per EN/IEC 60601-1-2 (2001). Software validation performed according to established protocols. No clinical data presented.

Technological Characteristics

Solid-state X-ray imager; USB 2.0 interface. Sensor thickness 4.9mm. Pixel size 0.35um x 0.35um. Connectivity: Wired USB to interface box, then to PC. Standards: EN/IEC 60601-1 (safety), EN/IEC 60601-1-2 (EMC).

Indications for Use

Indicated for dental patients requiring intra-oral x-ray examinations for diagnostic imaging.

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

• Schick CDR (K072134)

Submission Summary (Full Text)

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K090526

# 510(k) Summary

| Prepared: | September 1, 2009 |
|-----------|-------------------|
|-----------|-------------------|

## - 2 2009

### 1. Submitter:

| Company Name | : E-WOO Technology Co., Ltd. |
|--------------------|------------------------------------------------------------------------------------------------------|
| Company Address | : 1F, 4F, Yunmin Technotown, 473-4, Bora-dong, Giheung-gu,<br>Yongin-si, Gyeonggi-do, 446-904, Korea |
| U.S. Agent Address | : 256 N. Sam Houston Pkwy E. #115<br>Houston, TX 77060 |
| Contact person | : Vincent Lee |
| Phone Number | : [phone] |
| Fax Number | : [phone] |

- 2. Identification of the Device :

| Reason for 510(k) | : New Model |
|---------------------|---------------------------------|
| Manufacturer | : E-WOO Technology Co., Ltd |
| Trade Name | : E-Woo Technology |
| Model Name | : EzSensor |
| Classification Name | : MQB, Solid State X-ray Imager |
| FDA 510(k) # | : K090526 |

- 3. Equivalent legally marketed device :

| Manufacturer | : Schick Technologies, Inc. |
|---------------------|---------------------------------|
| Trade Name | : Schick |
| Model Name | : CDR |
| Classification Name | : MQB, Solid State X-Ray Imager |
| FDA 510(k) # | : K072134 |

- 4. 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.

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- 5. Description of the device :
The EzSensor is a solid state x-ray imager designed for dental radiographic applications. The EzSensor provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port.

#### The EzSensor configuration

- イ PC
- イ Image Interface Box (Read-out Box)
- イ X-ray sensor

Image /page/1/Figure/7 description: The image shows a diagram of a sensor system connected to a computer. The system includes a sensor connected to an image interface box via a sensor cable. The image interface box is connected to a computer via a USB cable, and the computer is connected to a display.

ﻟﻤﺰﺓ ﻳ

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### 510(k) Submission – EzSensor

| | Predicate:<br>CDR (K072134) | Proposed:<br>EzSensor (K090526) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Image: CDR (K072134) | Image: EzSensor (K090526) |
| Common/<br>Classification<br>Name | Solid State X-Ray Imager | Solid State X-Ray Imager |
| Intended Use | The Computed Oral Radiology<br>System is intended for intra-oral x-ray<br>examinations and indicated for dental<br>patients. It produces instant, digital,<br>intra-oral x-ray images of a patient's<br>mouth while reducing the necessary x-<br>ray dosage. | EzSensor, Intra-oral Imaging System,<br>is intended to collect dental x-ray<br>photons and convert them into<br>electronic impulses that may be<br>stored, viewed, and manipulated for<br>diagnostic use by dentists. |
| Device Description | - | The EzSensor is a solid state x-ray<br>imager designed for dental<br>radiographic applications. The<br>EzSensor provides digital image<br>capture for conventional film/screen<br>radiographic dental examinations. The<br>device is used to replace radiographic<br>film/screen systems in general dental<br>diagnostic procedures. The captured<br>digital image is transferred to Personal<br>Computer via USB interface port. |
| Sensor Dimensions (mm) | Size "0": 31x22<br>Size "1": 37x24<br>Size "2": 43x30 | Size "1.0": 35.7x25.2<br>Size "1.5": 38.7x29.2 |
| Sensor Thickness (mm) | 5 | 4.9 |
| Active Area (mm) | Size "0": 24x18<br>Size "1": 30x20<br>Size "2": 36x25.6 | Size "1.0": 20.02x30.03<br>Size "1.5": 24.08x31.85 |
| USB Module | Integrated USB 2.0 module | Integrated USB 2.0 module |
| Pixel Size (um) | 0.40x0.40 | 0.35x0.35 |

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- 6. Safety and Effectiveness, comparison to predicate device

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- 7. Safety, EMC and Performance Data :
In all material respects the "EzSensor" is substantially equivalent to CDR of Schick Technologies, Inc. (K072134) - Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory. 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.

- Testing information and Conclusion 8.
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 EzSensor is safe and effective and substantially equivalent to predicate devices as described herein.

- 9. E-WOO Technology Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", arranged in a circular fashion.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

DEC - 2 2009

E-Woo Technology Co., Ltd. % Mr. Vincent Lee Regulatory Compliance Officer E-Woo Technology USA, Inc. 256 North Sam Houston Pkwy E. #115 HOUSTON TX 77060

Re: K090526

Trade/Device Name: EzSensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 8, 2009 Received: October 13, 2009

#### Dear Mr. Lee:

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 your be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdaggov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lucia M. Merritt

Janine M. Morris Acting 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

K CG 05 26 510(k) Number(if known):

Device Name: EzSensor

Indications for Use:

The EzSensor is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (Part 21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation(ODE)

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

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