DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC

K122173 · Rayence Co., Ltd. · MQB · Oct 19, 2012 · Radiology

Device Facts

• Record ID: K122173
• Device Name: DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
• Applicant: Rayence Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Oct 19, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

1717SCC 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

1717SCC is a digital solid-state X-ray detector using flat-panel technology; consists of a Cesium Iodide scintillator coupled to an amorphous silicon (a-Si) TFT sensor. Device integrates into general radiographic systems (upright stands, tables, or portable units) to capture and digitize X-ray images. RAW image data is output for processing into DICOM-compatible files by separate console software (not part of this submission). Operated by clinical staff in diagnostic settings. Improved resolution and sharpness compared to predicate due to smaller pixel size (127 µm) and new bonding mechanism. Lighter weight (5.3 kg) achieved via stainless steel casing and structural design changes. Provides high-quality digital images for radiographic diagnosis, benefiting patients through improved image accuracy and reduced artifacts.

Clinical Evidence

Clinical evidence included an expert review of clinical images by a licensed US radiologist. Images from both the 1717SCC and the predicate Xmaru1717 were evaluated across various age groups and anatomical structures. Non-clinical bench testing included MTF, DQE, and NPS analysis per IEC 6220-1, demonstrating improved resolution and DQE performance for the 1717SCC.

Technological Characteristics

Detector: Amorphous Silicon (a-Si) TFT; Scintillator: Cesium Iodide (CsI); Pixel matrix: 3328 x 3328; Pixel pitch: 127 µm; A/D conversion: 14-bit; Dimensions: 460 x 460 x 15.9 mm; Weight: 5.3 kg; Casing: Stainless steel. Connectivity: RAW data output for external DICOM processing. Safety/EMC: IEC 60601-1:2005, IEC 60601-1-2:2007.

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

• Xmaru1717 (K091090)

Submission Summary (Full Text)

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K122173

510(k) Submission – 1717SCC

# 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 510K summary prepared: August 31st, 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 Iro gil,<br>Hwaseong-Si, Gyeonggi-Do, 445-170,<br>Republic of Korea |
| Submitter's Telephone: | [phone] |
| Contact person: | Mr. Kee Dock Kim / Manager |
| Official Correspondent:<br>(U.S. Designated agent) | Dave Kim ([e-mail]) |
| 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: | 1717SCC |
|-------------------------|----------------------------------------------------------|
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name : | 21CFR 892.1650, Solid State X-ray Imaging Device, Class2 |
| Product Code: | MQB |

Rayence Co., Ltd.

# OCT 1 9 2012

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#### 510(k) Submission - 1717SCC

#### Predicate Device :

SIOS : Manufacturer Device 510(k) Number

: Rayence Co.,Ltd. : Xmaru1717 : K091090 (Decision Date - SEP 9. 2010)

#### Device Description :

1717SCC is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by separate console SW (not part of this 510k submission) for a radiographic diagnosis and analysis.

#### Indication for use :

1717SCC 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.

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

The 1717SCC SSXI detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, Xmaru1717, of Rayence Co., Ltd. Table 1 summarizes the technological characteristics of the 1717SCC and Xmaru1717 the predicate device.

| Characteristic | Proposed<br>Rayence Co.,Ltd.<br>1717SCC | Predicate<br>Rayence Co.,Ltd.<br>Xmaru1717 |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K091090 |
| Intended Use | 1717SCC 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. | 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. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | Cesium Iodide | Gadolinium Oxysulfide |
| Imaging Area | 17 x 17 inches | 17 x 17 inches |
| Pixel matrix | 3328 x 3328 (10 million) | 3072 x 3072 (9 million) |
| Pixel pitch | 127 $\mu$ m | 143 $\mu$ m |
| Resolution | 3.9 lp/mm | 3.5 lp/mm |
| A/D conversion | 14 bit | 14 bit |
| Grayscale | 16384 (14bit) | 16384 (14bit) |
| Preview Image | 3~4 seconds | 5 seconds per Image |
| Data output | RAW<br>*The RAW files are convertible into<br>DICOM 3.0 by console S/W | RAW<br>*The RAW files are convertible into<br>DICOM 3.0 by console S/W |
| Dimensions | 460 × 460 × 15.9 mm | 500 x 497 x 45 mm |
| Weight | 5.3 kg | 13.4 kg |
| Application | General Radiology system or<br>Portable system<br>Available with upright stand, table,<br>universal stand. | General Radiology system or<br>Portable system<br>Available with upright stand, table,<br>universal stand. |

Table 1: Comparison of 1717SCC and Xmaru1717

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.

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#### 510(k) Submission - 1717SCC

Image /page/3/Picture/1 description: The image shows two different views of a flat panel detector. The left image shows the detector with a handle on top and a crosshair in the center of the panel. The right image shows a close up of the flat panel detector, with a white label on the side.

#### Table 2: Comparison of 1717SCC and Xmaru1717

| Item | Unit | 1717SCC | Xmaru1717 |
|------------------------------------------------------|--------|-------------|-------------|
| Pixel size | μm | 127 x 127 | 143 x 143 |
| Total horizontal and<br>vertical size | mm | 426 x 426 | 439 x 439 |
| Total horizontal and<br>vertical element count | pixels | 3328 x 3328 | 3072 x 3072 |
| Active area horizontal and<br>vertical size | mm | 426 x 426 | 429 x 429 |
| Active area horizontal and<br>vertical element count | pixels | 3250 x 3250 | 3000 x 3000 |
| Pixel spacing | um | 127 | 143 |
| Fill factor | % | 63 | 68.30 |
| Weight | Kg | 5.3 Kg | 13.4 Kg |

Note: The weight of new sensor differs from the predicate sensor (Xmaru1717).

1. Change of the case material : The new sensor casing is done with stainless steel (lighter) instead of Aluminum (heavier). The result is approximately 5kg less weight for 1717 SCC detector compared with the Xmaru1717 detector, predicate device.

2. Panel : Unlike the new detector, the previous detector is bonded with the sub-glass panel, (the thickness of 2.9mm). The result is approximately 1.5kg less weight for 1717SCC.

3. Lighter Main BD Block(Structure between the Panel and Main BD) : Approximately 1kg less weight

4. Lighter Main BD : Approximately 0.7kg less weight

#### Summary of Performance Testing:

Indications for use, material, form factor, performance, and safety characteristics between 1717SCC and the predicate device are very similar. The primary difference is Pixel size, Pixel matrix, Pixel pitch, Resolution and Scintillator materials; Cesium iodide(CsI) for 1717SCC and GOS(Gd202S:Tb) for Xmaru1717, respectively. The non-clinical test report and clinical consideration report were prepared and submitted to FDA separately to demonstrate the substantial

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equivalency between two different detectors. The non-clinical test report contains the MTF, DQE and NPS test results of 1717SCC and Xmaru1717 by using the identical test equipment and same analysis method described by IEC 6220-1 The comparisoin of the MTF for 1717SCC and Xmaru1717 detector demonstated that the MTF of the Xmaru1717 detector performed better than 1717SCC. Nevertheless, the new detector 1717SCC utilizes a new bonding mechanism to narrow the gap between the panel and scintillator. Moreover, the pixel size of the new detector 1717SCC

is 127 um smaller than 143 um of Xmaru1717. Thereofre, the overall resolution performance and

shapness of 1717SCC is better than Xmaru1717 which results improvement of the ability of the new detector to represent distinct anatomic features whitin the imaged object. The DQE represents the ability to visualize object details of a certain size and contrast. 1717SCC demonstrated better DQE performance than Xmarul 717 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 1717SCC is much lower than Xmaru1717; 0.223 and 0.38 respectively. The reduced noise has imporved the accuracy of image and reduced the degree of artifacts for the new detector. 1717SCC exhibited NPS which has lower performance than Xmaru1717. Therefore, the image quality of 1717SCC is greater than Xmaru1717 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 (1717SCC) and control group (Xmaru1717) 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 for1717SCC compared to the predicate device, Xmaru1717.

#### Safety, EMC and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:2005(Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) + CORR.1(2006) + CORR.2 (2007) / EN 60601-1:2006 / was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007(Medical electrical equipment - Part 1-2: General Requirements for safety - Collateral Standard :

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Electromagnetic Compatibility Requirements and tests) / EN 60601-1-2:2007. 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 1717SCC is safe and effective and substantially equivalent in comparison with the predicate device as described herein.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.

Public Health Service

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

OCT 1 9 2012

Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberely Lane HOUSTON TX 77079

Re: K122173

Trade/Device Name: Digital Flat Panel X-Ray Detector/1717SCC Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: July 13, 2012 Received: August 20, 2012

#### 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.

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

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):

KI22)73

Device Name: Digital Flat Panel X-Ray Detector /1717SCC

Indications for Use:

1717SCC 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 o 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)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Page 1 of 1

Michael D'Ohm

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) K122173