DIGITAL FLAT PANEL X-RAY DETECTOR

K112558 · Samsung Mobile Display Co., Ltd. · MQB · Nov 10, 2011 · Radiology

Device Facts

• Record ID: K112558
• Device Name: DIGITAL FLAT PANEL X-RAY DETECTOR
• Applicant: Samsung Mobile Display Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Nov 10, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

SDX-4343GV digital flat panel X-Ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

Device Story

Digital flat panel X-ray detector; captures X-ray radiation via scintillator coupled to a-Si TFT sensor; converts X-ray energy into digital RAW image files. Integrated with external X-ray generator and operating PC; outputs RAW files for conversion to DICOM format. Used by physicians and healthcare professionals in clinical settings for radiographic diagnosis and treatment planning. Replaces film-based systems; provides high-resolution, high-sensitivity digital imaging for general anatomy.

Clinical Evidence

Bench testing only. Performance verified through electrical, mechanical, and environmental safety testing per EN/IEC 60601-1 and EMC testing per EN/IEC 60601-1-2, EN/IEC 61000-3-2, and EN/IEC 61000-3-3. No clinical data provided.

Technological Characteristics

Digital flat panel X-ray detector; scintillator coupled to a-Si TFT sensor; generates digital RAW files. Connectivity via integration with operating PC and X-ray generator. Complies with EN/IEC 60601-1 (safety) and EN/IEC 60601-1-2 (EMC).

Indications for Use

Indicated for general radiographic diagnosis of human anatomy in adults and children. 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

• LLX240AB01 (K012587)

Submission Summary (Full Text)

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### 510(k) Submission - SDX-4343GV

## Special 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.

NOV 1 0 2011

Date: ________________________________________________________________________________________________________________________________________________________________________

1. Company and Correspondent making the submission:

Samsung Mobile Display Co., Ltd. Name -

Address - San #24, Nongseo-Dong, Giheung-Gu, Yongin-Si,

Gyeonggi-Do, Korea, 446-711

Telephone - [phone]

Fax - [phone]

Contact - Mr. Kyung Hun Yoon / Senior Manager Internet - http://www.SAMSUNG.com

- 2. Device :

| Trade/proprietary name(s) | : SDX-4343GV |
|---------------------------|-------------------------------------|
| Common Name | : Digital Flat Panel X-Ray Detector |
| Classification Name | : Solid State X-ray Imaging Device |

- 3. Predicate Device :

| Manufacturer | : Samsung Mobile Display Co., Ltd |
|------------------------|----------------------------------------------------|
| Device(s) and 510K No. | : LLX240AB01(K012587, Decision Date - Dec 1, 2010) |

- 4. Classifications Names & Citations :
21CFR 892.1650, MQB, Solid State X-ray Imaging Device, Class2

- 5. Description :
- 5.1 General

SDX-4343GV digital X-ray flat panel detectors can generate radiographic images of any part of the body. Each of them consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4343GV is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray

Samsung Mobile Display Co., Ltd.

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### 510(k) Submission - SDX-4343GV

images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by the user's designated console software which is not included in SDX-4343GV, digital flat panel X-ray detector.

#### 6. Indication for use :

SDX-4343GV digital flat panel X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

- 7. Comparison with predicate device :
Samsung Mobile Display Co., Ltd., believes that SDX-4343GV is substantially equivalent to the predicate devices: LLX240AB01.

- 8. Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard ENVIEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2007), EN/IEC 61000-3-2:2006+A2:2009 and EN/IEC 61000-3-3:2008. All test results were satisfactory.

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 SDX-4343GV is safe and effective and substantially equivalent to its predicate device as described herein.

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

Samsung Mobile Display Co., Ltd.

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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a stylized eagle emblem on the left, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a clear, sans-serif font. The text is aligned horizontally and is in a blue color.

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. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberly Lane HOUSTON TX 77079

AUG 2 3 2013

Re: K112558

Trade/Device Name: Digital Flat Panel X-Ray Detector/SDX-4343GV Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: October 18, 2011 Received: October 21, 2011

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of November 10. 2011.

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 for ass stated in the encrosal 0776, 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 I va may, mereloro, mains 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 or any 1 vith 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 mouirements 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 witi anow you to oogin finding of substantial equivalence of your device to a legally marketed predication. The I Drin intellig or section 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 Pars 801 and If you desire specific antive of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-007), prease vonaot 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 under the MDA regulation (2) "CFFF at 000), promo gooders/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 Tou may 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

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# Indications for Use

510(K) Number (if known): K112558

Device Name: Digital Flat Panel X-Ray Detector /SDX-4343GV

Indications for Use:

SDX-4343GV digital flat panel X-Ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. 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)

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign. Off) Division of Asdiological Devices Office of In Vitro Diagnestic Device Evaluation and Sefety Page 1 of 1

510K K112558