DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA

K122928 · Rayence Co., Ltd. · MQB · Jan 30, 2013 · Radiology

Device Facts

• Record ID: K122928
• Device Name: DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
• Applicant: Rayence Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Jan 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

1417PGA 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

1417PGA is a portable digital X-ray flat panel detector; consists of a Gadolinium Oxysulfide scintillator coupled to an a-Si TFT sensor. Device integrates with an X-ray generator and operating PC to capture X-ray signals; transforms inputs into RAW digital files. Console software converts RAW files into DICOM-compatible images for radiographic diagnosis. Used in clinical settings (upright stands, tables, universal stands) by physicians and radiologists. Output allows visualization of anatomical features; aids in diagnostic decision-making. Benefits include high-resolution, high-sensitivity imaging with reduced noise compared to film-based systems.

Clinical Evidence

Clinical evidence consisted of an expert review of clinical images taken from both the 1417PGA and the predicate device. Images were evaluated by a licensed US radiologist across various age groups and anatomical structures to confirm diagnostic equivalence. No formal clinical trial with statistical endpoints was required; substantial equivalence was primarily supported by non-clinical bench testing (MTF, DQE, NPS) demonstrating improved resolution and SNR compared to the predicate.

Technological Characteristics

Detector: Amorphous Silicon (a-Si) TFT; Scintillator: Gadolinium Oxysulfide (Gd2O2S:Tb); Pixel matrix: 3328 x 2816; Pixel pitch: 127 μm; A/D conversion: 14-bit; Dimensions: 460 x 417 x 15.9 mm; Weight: 3.6 kg; Connectivity: DICOM 3.0 via console software; Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for digital imaging in general radiographic systems for human anatomy; intended to replace film/screen 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

• SDX-4336CP (K102321)

Submission Summary (Full Text)

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510(k) Submission – 1417PGA

### 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 510K summary prepared: September 21, 2012

Submitter's Name, address, telephone number, a contact person:

| Submitter's Name : | Rayence Co., Ltd. |
|-------------------------|--------------------------------------------|
| Submitter's Address: | (Seogu-dong, 2F/4F) 14, Samsung 1ro 1-gil, |
| | Hwasung-si, Gyeonggi-do, 445-170, Korea |
| Submitter's Telephone: | [phone] |
| Contact person: | Mr. Kee Dock Kim / Manager |
| Official Correspondent: | Dave Kim ([e-mail]) |
| (U.S. Designated agent) | |
| Address: | 12946 Kimberley Ln, Houston, TX 77079 |
| Telephone: | [phone] |
| Fax: | [phone] |

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

| Trade/proprietary name: | 1417PGA |
|---------------------------|------------------------------------------|
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name : | Solid State X-ray Imaging Device, Class2 |
| Regulation Number / Name: | 21CFR 892.1680 / Stationary X-ray system |

Rayence Co., Ltd.

# JAN 3 0 2013

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#### 510(k) Submission - 1417PGA

| Product Code: | MQB |
|--------------------|-------------------------------------------|
| Predicate Device : | |
| Manufacturer | : Samsung Mobile Display Co., Ltd. |
| Device | : SDX-4336CP |
| 510(k) Number | : K102321 (Decision Date - Feb. 11. 2011) |

#### Device Description :

The 1417PGA is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-Si TFT sensor. It makes high-resolution, high-sensitive digital images. 1417PGA 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 console SW.

#### Indication for use :

1417PGA 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.

#### Rayence Co., Ltd.

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#### Summary of the technological characteristics of the device compared to the predicate device:

1417PGA SSXI detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, SDX-4336CP, of Samsung Mobile Display Co., Ltd. Table 1 summarizes the technological characteristics of the 1417PGA and SDX-4336CP the predicate device.

| Characteristic | Proposed<br>Rayence Co.,Ltd.<br>1417PGA | Proposed<br>Samsung Mobile Display<br>Co., Ltd.<br>SDX-4336CP |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K102321 |
| Intended Use | 1417PGA Digital Flat Panel<br>X-Ray Detector is indicated<br>for digital imaging solution<br>designed for general<br>radiographic system for<br>human anatomy. It is<br>intended to replace film or<br>screen based radiographic<br>systems in all general<br>purpose diagnostic<br>procedures. Not to be used<br>for mammography. | SDX-4336CP Digital Flat Panel<br>X-Ray Detector is indicated for<br>digital imaging solution designed<br>for providing general<br>radiographic diagnosis of human<br>anatomy targeting both adult and<br>children. It is intended to be used<br>by physicians and radiologists.<br>and not to be used for<br>mammography. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | Gadolinium Oxysulfide | Cesium Iodide |
| Imaging Area | 14 x 17 inches | 14 x 17 inches |
| Pixel matrix | 3328 x 2816 (9.4 million) | 2880 x 2400 (6.9 million) |
| Pixel pitch | 127 $\mu$ m | 150 $\mu$ m |
| Resolution | 3.9lp/mm | 3.3lp/mm |

#### Table 1: Comparison of 1417PGA and SDX-4336CP ·

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#### 510(k) Submission - 1417PGA

| A/D conversion | 14 bit | 14 bit |
|----------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Grayscale | 16384 (14bit) | 16384 (14bit) |
| Preview Image | 2~3 seconds | 2~3 seconds |
| Data output | RAW<br>*The RAW files are<br>convertible into DICOM 3.0<br>by console S/W | RAW<br>*The RAW files are<br>convertible into DICOM 3.0<br>by console S/W |
| Dimensions | 460 x 417 x 15.9 mm | 491 × 480 × 15 mm |
| Weight | 3.6 kg | 3.8 kg |
| Application | Portable system<br>Available with upright stand,<br>table, universal stand | Portable system<br>Available with upright stand,<br>table, universal stand |
| Feature | Image: black box with handle | Image: gray surface with handle |

#### Table 2: Comparison of 1417PGA and SDX-4336CP

| Item | Unit | 1417PGA | SDX-4336CF |
|------------------------------------------------------|--------|---------------|-------------|
| Pixel size | μm | 127 x 127 | 150 x 150 |
| Total horizontal and<br>vertical size | mm | 422.7 x 357.6 | 432 x 360 |
| Total horizontal and<br>vertical element count | pixels | 3328 x 2816 | 2880 x 2400 |
| Active area horizontal and<br>vertical size | mm | 416.6 x 351.8 | 423 x 351 |
| Active area horizontal and<br>vertical element count | pixels | 3280 x 2770 | 2820 x 2340 |
| Pixel spacing | μm | 127 | 150 |
| Fill factor | % | 65.14 | 68.5 |
| Weight | Kg | 3.6 Kg | 3.8 Kg |

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#### Summary of Performance Testing:

Indications for use, material, form factor, performance, and safety characteristics between 1417PGA and the predicate device are very similar. The primary difference is Pixel size, Pixel matrix, Pixel pitch, Resolution and Scintillator materials; GdOS(Gd2O2S:Tb) for 1417PGA and Cesium iodide(Csl) for SDX-4336CP, respectively. The non-clinical test report and clinical consideration report were prepared and submitted to FDA separately to demonstrate the substantial equivalency between two different detectors. The non-clinical test report contains the MTF, DQE and NPS test results of 1417PGA and SDX-4336CP by using the identical test equipment and same analysis method described by IEC 62220-1. The comparisoin of the MTF for 1417PGA and SDX-4336CP detector demonstated that the MTF of the 1417PGA detector performed better than SDX-4336CP at 0~2.2 lp/mm. Also, the new detector 1417PGA utilizes a new bonding mechanism to narrow the gap between the panel and scintillator. Moreover, the pixel size of the new detector

1417PGA is 127 um which is smaller than 143 um of SDX-4336CP. Thereofre, the overall

resolution performance and sharpness of 1417PGA is better than SDX-4336CP which results improvement of the ability of the new detector to represent distinct anatomic features whitin the imaged object. The DOE represents the ability to visualize object details of a certain size and contrast. 1417PGA demonstrated better DQE performance than SDX-4336CP at various spatial frequencies and provides a higher Signal-toNoise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. At the zero-frequency DQE values for 1417PGA is higher than SDX-4336CP; 0.761 and 0.740 respectively. The reduced noise has imporved the accuracy of image and reduced the degree of artifacts for the new detector. 1417PGA exhibited NPS which has lower performance than SDX-4336CP. Therefore, the image quality of 1417PGA is greater than SDX-4336CP at the same patient exposure.

To further demonstrate the substantial equivalency of two devices, clinical images are taken from both devcies and reviewd by a licensed US radiologist to render an expert opinion. Both test (1417PGA) and control group (SDX-4336CP) are evaluated according to age group and anatomical structures were compared in accordance with the test protocol of diagnostic radiography evaluation procedure.

Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisions for both devices, we can claim equivalent or better diagnostic image quality for1417PGA compared to the predicate device, SDX-4336CP.

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#### Safety, EMC and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:1998+A1:1999+A2:1995(Medical electrical equipment Part 1: General Requirements for Safety) was performed, and EMC testing were conducted in accordance with standard (Medical electrical equipment - Part 1-2: General Requirements for safety - Collateral Standard : Electromagnetic Compatibility Requirements and tests).

Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.

#### 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 Rayence Co., Ltd. concludes that 1417PGA is safe and effective and substantially equivalent in comparison with the predicate device as described herein.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized representation of human figures.

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

#### January 30, 2013

Ravence Co., LTD. C/Q Dave Kim Mtech Group 12946 Kimberley Lane HOUSTON TX 77079

Re: K122928

Trade/Device Name: Digital Flat Panel X-ray Detector 1417PGA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: January 16, 2013 Received: January 26, 2013

#### Dear Mr. Kim:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may 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 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.

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Page 2-Mr. Kim

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

Sincerely yours,

# Sean M. Boyd -S for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### 510(k) Number (if known): K122928

Device Name: Digital Flat Panel X-Ray Detector /1417PGA

Indications for Use:

1417PGA 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 X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

# Sean M. Boyd

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)

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