DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717

K091090 · E-Woo Technology · MQB · Aug 9, 2010 · Radiology

Device Facts

• Record ID: K091090
• Device Name: DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
• Applicant: E-Woo Technology
• Product Code: MQB · Radiology
• Decision Date: Aug 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

Xmaru1717 Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

Device Story

Xmaru1717 is a TFT-based flat panel X-ray detector; converts transmitted X-rays into digital information. Integrated with an operating PC and X-ray generator; used in clinical settings for general radiography. Device digitizes X-ray images; enables image management and real-time sharing over networks. Healthcare providers use the digital output for diagnostic assessment; replaces traditional film/screen systems. Benefits include efficient diagnosis and streamlined information management.

Clinical Evidence

Bench testing only. Electrical, mechanical, and environmental safety and performance testing conducted per EN/IEC 60601-1. EMC testing conducted per EN/IEC 60601-1-2 (2001). All test results were satisfactory.

Technological Characteristics

TFT-based flat panel X-ray detector. Dimensions/form factor: 17x17. Connectivity: Networked integration with operating PC and X-ray generator. Standards: EN/IEC 60601-1 (safety), EN/IEC 60601-1-2 (EMC).

Indications for Use

Indicated for digital radiographic imaging of human anatomy in general purpose diagnostic procedures. Contraindicated for mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only 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

• CXDI-50G (K031447)
• DRC-1000, Digital X-ray Imaging System (K092830)

Submission Summary (Full Text)

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## 510(k) Summary

### AUG - 9 2010

This summary of 510(k) safety and effectiveness information is updated citing K092830, DRC-1000, digital X-ray imaging system as a predicate and the device is a subset of components of the K092830, DRC-1000 digital X-ray imaging system with the same technological characteristics in accordance with requirements of 21 CFR Part 807.92.

Date: July 23, 2010

1. Company and Correspondent making the submission:

Name - E-Woo Technology Co., Ltd.

Address - 1F, 4F, Yunmin Technotown 473-4 Bora-Dong, Giheung-Gu, Yong in-Si, Gyeong gi-Do, Korea, 446-904

Telephone - [phone]

Fax - [phone]

Contact - Mr. Jason Park / Assistant Manager

Internet - http://www.e-wootech.com

- 2. Device :

| Trade/proprietary name | : Xmaru1717 |
|------------------------|-------------------------------------|
| Common Name | : Digital Flat Panel X-Ray Detector |
| Classification Name | : Solid State X-ray Imaging Device |

- 3. Predicate Devices :

| Manufacturer | : Canon Inc. |
|---------------|-------------------------------------------|
| Device | : CXDI-50G |
| 510(k) Number | : K031447 (Decision Date - May. 21. 2003) |

| Manufacturer: | Vatech Co. Ltd |
|---------------|----------------------------------------|
| Device: | DRC-1000, Digital X-ray Imaging System |
| 510(k) Number | K092830 |

4. Classifications Names & Citations :

E-woo Technology Co., Ltd.

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#### 510(k) Submission - Xmaru1717

21CFR 892.1650, MQB, Solid State X-ray Imaging Device, Class2

#### 5. Description :

- 5.1 General
Xmaru1717 is the TFT-based Flat Panel X-Ray Detector that keeps this Digitally based World going forward by providing the most important solution converting transmitted X-Ray into Digital Information.

Xmaru1717 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network.

#### 5.2 Product features

Xmaru1717 is an X-Ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and a X-Ray generator. It can do to utilize as digitalizing x-ray images and transfer for radiography diagnostic

#### 6. Indication for use :

Xmaru1717 Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

- 7. Comparison with predicate device :
E-Woo Technology Co., Ltd., believes that the Xmaru1717 is substantially equivalent to the CXDI-50G of Canon Inc. and the device is a subset of components of the K092830, DRC-1000 digital X-ray imaging system from Vatech Co. Ltd, with the same technological characteristics in accordance

- 8. Safety, EMC and Performance Data :
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.

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9. Conclusions :

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 Xmaru1717 is safe and effective and substantially equivalent to predicate devices as described herein.

- 10. E-Woo Technology Co., Ltd. will update and include in this summary any other information deemed seasonably necess ary by the FDA.
END

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in blue, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written in a clear, sans-serif font. To the left of the text is a symbol featuring a stylized representation of human figures, also in blue, which is part of the department's official emblem.

Public Health Service

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

E-Woo Technology % Mr. Vincent Lee Official Correspondent E-Woo Technology USA, Inc. 256 N. Sam Houston Pkwy E. Suite 115 HOUSTON TX 77060

AUG 2 3 2013

Re: K091090

Trade/Device Name: Digital Flat Panel X-Ray Detector/Xmaru1717 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: December 22, 2009 Received: December 28, 2009

Dear Mr. Lee:

This letter corrects our substantially equivalent letter of August 9, 2010.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

# K091090

510(k) Number(if known): KO91090

## AUG - 5 2010

Device Name: Digital Flat Panel X-Ray Detector /Xmaru1717

Indications for Use:

Xmaru1717 Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

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 Dev Sustination(SBE)

.

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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510K. Kb91090