DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A

K090742 · Samsung Mobile Display Co., Ltd. · MQB · Sep 18, 2009 · Radiology

Device Facts

• Record ID: K090742
• Device Name: DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
• Applicant: Samsung Mobile Display Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

LTX240AA01-A 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 to in all general purpose diagnostic procedures. Not to be used for mammography.

Device Story

LTX240AA01-A is a TFT-based flat-panel X-ray detector; converts transmitted X-rays into digital information. Device integrates with an operating PC and X-ray generator to acquire, digitize, and transfer radiographic images for diagnostic purposes. Used in clinical settings by healthcare professionals; facilitates efficient diagnosis, information management, and real-time image sharing over networks. Benefits include transition from analog film/screen systems to digital radiography, enabling improved workflow and image accessibility.

Clinical Evidence

Bench testing only. Performance data included electrical, mechanical, and environmental safety testing per EN/IEC 60601-1 and EMC testing per EN/IEC 60801-1-2. All test results were satisfactory.

Technological Characteristics

TFT-based flat-panel X-ray detector. Integrates with external X-ray generator and PC. Complies with EN/IEC 60601-1 (safety) and EN/IEC 60801-1-2 (EMC).

Indications for Use

Indicated for digital imaging in general radiographic systems for human anatomy. Intended to replace film/screen-based systems for general 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

• Canon Inc. CXDI-50G (K031447)

Submission Summary (Full Text)

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

#### K090742 500 1 510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: _Jan. 27, 2009

- 1. Company and Correspondent making the submission:
Name - Samsung Mobile Display Co., Ltd.

Address - San #24, Nongseo-Dong, Giheung-Gu, Yongin-Si, Gyeonggi-Do, Korea, 446-711

Telephone - [phone]

Fax - [phone]

Contact - Mr. Jooha Park / Senior Manager

Internet - http://www.SAMSUNG.com

- 2. Device :
1

| Trade/proprietary name | : LTX240AA01-A |
|------------------------|-------------------------------------|
| Common Name | : Digital Flat Panel X-Ray Detector |
| Classification Name | : Solid State X-ray Imaging Device |

3. Predicate Device :

| Manufacturer | : Canon Inc. |
|---------------|-------------------------------------------|
| Device | : CXDI-50G |
| 510(k) Number | : K031447 (Decision Date - Mar. 26. 2003) |

4. Classifications Names & Citations :

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

5. Description :

5.1 General

Samsung Mobile Display Co., Ltd.

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

510(k) Submission - LTX240AA01-A

Living at the heart of a Digitally enabled society evolving to endless range of applications from Consumer Mobile Display to Medical X-Ray and more to Industrial, Security all beyond our imagination. It's 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. Under the Vision of "Deliver Digitally enriched Images for Visually enabled World!". Now Samsung Mobile Display is thrilled in bringing the first TFT-based Flat Panel X-Ray Detector to this prominent Medical industry.

LTX240AA01-A 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

LTX240AA01-A 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 :

LTX240AA01-A 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 :

Samsung Mobile Display Co., Ltd., believes that the LTX240AA01-A is substantially equivalent to the CXDI-50G of Canon Inc.,

### 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 60801-1-2(2001). All test results were satisfactory.

Samsung Mobile Display Co., Ltd.

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

510(k) Submission – LTX240AA01-A

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 Samsung Mobile Display Co., Ltd. concludes that The LTX240AA01-A is safe and effective and substantially equivalent to predicate devices as described herein.

- 10. Samsung Mobile Display Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
### END

page Sot 3

### Samsung Mobile Display Co., Ltd.

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

Image /page/3/Picture/0 description: The image is a circular logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol in the center, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

# 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

Samsung Mobile Display Co., Ltd. % Mr. Vince Lee Manager E-WOO Technology USA, Inc. 256 North Sam Houston Pkwy E., Suite 115 HOUSTON TX 77060

AUG 23 2013

Re: K090742

Trade/Device Name: Digital Flat Panel X-Ray Detector/LTX240AA01-A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 1, 2009 Received: September 11, 2009

Dear Mr. Lee:

This letter corrects our substantially equivalent letter of September 18, 2009.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave and have 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 for use stated in the enorosure) to 10gail) to 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 I va mayy diores or visions 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 11 Jour controls. Existing major regulations affecting your device can be found in Title 21, additional controls. Diaming may 1. 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

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

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

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

Enclosure

{5}------------------------------------------------

# Indications for Use

### 510(k) Number(if known): K 09074 2 SOO l

Device Name: Digital Flat Panel X-Ray Detector /LTX240AA01-A

Indications for Use:

LTX240AA01-A Digital Flat Painel 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 to in all general purpose diagnostic procedures. Not to be used for mammography.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Consurrence of CDRH, Office of Device Evaluation(ODE)

logun In Whain

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

Page 1 of _1