SDX-4343CS

K112751 · Samsung Mobile Display Co., Ltd. · MQB · Nov 23, 2011 · Radiology

Device Facts

• Record ID: K112751
• Device Name: SDX-4343CS
• Applicant: Samsung Mobile Display Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Nov 23, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

SDX-4343CS Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. 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 who are licensed by the law of the State in which he or she practices to use the device. Not to be used for mammography.

Device Story

The SDX-4343CS is a digital flat panel X-ray detector used to generate radiographic images of human anatomy. It consists of a scintillator coupled to an a-SI TFT sensor. The device captures X-ray radiation and converts it into digital RAW files. These files are transmitted to an external operating PC and X-ray generator, where they are converted into DICOM-compatible images for diagnostic review by licensed healthcare professionals. The device is intended for use in clinical settings to replace film-based radiographic systems, facilitating diagnosis and treatment planning. It does not include the console software required for image processing and display.

Clinical Evidence

Bench testing only. Performance, electrical, mechanical, and environmental safety testing conducted in accordance with EN/IEC 60601-1 and EN/IEC 60601-1-2 standards. No clinical data provided.

Technological Characteristics

Scintillator directly coupled to an a-SI (amorphous silicon) TFT sensor. Digital flat panel form factor. Connectivity via integration with external PC and X-ray generator. Standards: EN/IEC 60601-1 (safety), EN/IEC 60601-1-2 (EMC).

Indications for Use

Indicated for digital radiographic diagnosis of human anatomy in adults and pediatric patients. Not 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

• SDX-4336CP (K012321)

Submission Summary (Full Text)

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Special 510(k) Submission - SDX-4343CS

## KII2751 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.

Date: September 15th, 2011

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

- 2. Official Correspondent for this submission
Contact - Dave Kim Address - 12946 Kimberley Ln, Houston, TX 77079 Tel : [phone] Fax : [phone] Email : [e-mail]

- 3. Device :

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

- 4. Predicate Device :

| Manufacturer | : Samsung Mobile Display Co., Ltd |
|------------------------|--------------------------------------------------------|
| Device(s) and 510K No. | : SDX-4336CP (K012321, Decision Date - Feb 11, 2011) - |

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

Samsung Mobile Display Co., Ltd.

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## 6. Description :

- 6.1 General
SDX-4343CS 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-4343CS is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray 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-4343CS, digital flat panel X-ray detector.

- 7. Indication for use :
SDX-4343CS Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. 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 who are licensed by the law of the State in which he or she practices to use the device. Not to be used for m am mography .

- 8. Comparison with predicate device :
Samsung Mobile Display Co., Ltd., believes that SDX-4343CS is substantially equivalent to the predicate devices; SDX-4336CP.

- 9. 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 ENVIEC 60601-1-2(2001). 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-4343CS is safe and effective and substantially equivalent to its predicate device as described herein.

Samsung Mobile Display Co., Ltd.

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## Special 510(k) Submission - SDX-4343CS

- 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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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: K112751

Trade/Device Name: Digital Flat Panel X-Ray Detector/SDX-4343CS Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: November 16, 2011 Received: November 7, 2011

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of November 23. 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 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 Cosmatic 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 or any I 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 mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as bet for in are qualibur device as described in your Section 510(k) premarket with anow you to oogin 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 11 you desire specific acries 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 I value 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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510(K) Number (if known):

K112751

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

Indications for Use:

SDX-4343CS Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. 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 who are licensed by the law of the State in which he or she practices to use the device. 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)

Muri D. O'th

810K k 112751

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