DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC

K122182 · Rayence Co., Ltd. · MQB · Aug 16, 2012 · Radiology

Device Facts

• Record ID: K122182
• Device Name: DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
• Applicant: Rayence Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Aug 16, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

1717SGC 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

1717SGC is a digital solid-state X-ray detector utilizing flat-panel technology; consists of a scintillator coupled to an a-Si TFT sensor. Device integrates into general radiographic systems to capture and digitize X-ray images. RAW files are transmitted to separate, non-included console software for DICOM-compatible processing, diagnosis, and analysis. Used in clinical settings by healthcare professionals; output assists clinicians in radiographic diagnosis. Benefits include transition from analog film/screen systems to digital imaging workflows.

Clinical Evidence

Bench testing only. Performance verified through electrical, mechanical, and environmental safety testing per IEC 60601-1:2005 and EMC testing per IEC 60601-1-2:2007. No clinical data provided.

Technological Characteristics

Digital flat-panel X-ray detector; scintillator coupled to a-Si TFT sensor. Standards: IEC 60601-1:2005 (safety), IEC 60601-1-2:2007 (EMC). Connectivity: Integrates with external radiographic imaging systems for RAW file output. Form factor: Flat panel.

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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510(k) Submission - 1717SGC

# 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: June 29, 2012

1. Company sponsoring this submission:

Name -Rayence Co., Ltd.

Address - (Seogu-dong, 2F/4F) 14, Samsung 1ro 1-gil, Hwaseong-si, Gyeonggi-do,

445-170, Korea

Telephone - [phone]

Fax - [phone]

Contact - Kee Dock Kim / Manager

Internet -- http://www.rayence.com

2. Official correspondent (U.S. Designated agent)

Mtech Group

12946 Kimberley Ln Houston, TX 77079

Tel: [phone]

Fax: [phone]

Contact person: Mr. Dave Kim

Email: [e-mail]

#### 3. Device :

| Trade/proprietary name | : 1717SGC |
|------------------------|-------------------------------------|
| Common Name | : Digital Flat Panel X-ray Detector |
| Classification Name | : Solid State X-ray Imaging Device |

#### 4. Predicate Device :

| Manufacturer | : Rayence Co.,Ltd. |
|---------------|-----------------------------------------------|
| Device | : Xmaru1717 |
| 510(k) Number | : K091090 (Decision Date - September 9, 2010) |

Rayence Co., Ltd.

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### 5. Classifications Names & Citations :

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

#### 6. Description :

- 6.1 General
1717SGC 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.

- 7. Indication for use :
1717SGC 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.

#### 8. Comparison with predicate device :

Rayence Co., Ltd. believes that 1717SGC is substantially equivalent in comparison with Xmaru1717 of Rayence Co., Ltd.

#### 9. 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.I(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 : Electromagnetic Compatibility Requirements and tests) / EN 60601-1-2:2007. All test results were satisfactory.

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- 10. 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.

- 11. Rayence Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by FDA.
.

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# 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

AUG 16 2012

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

Re: K122182

Trade/Device Name: Digital Flat Panel X-Ray Detector/1717SGC Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: June 29, 2012 Received: July 23, 2012

Dear Mr. Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your becaon 910(t) proxic 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 Clerosury to regar) many care of the Medical Device Amendments, or to comments. prior to May 20, 1970, the encordance with the provisions of the Federal Food, Drug, devices may becer reculissimou in ascee approval of a premarket approval application (PMA). alle Cosmetic Act (Act) that do novice, subject to the general controls provisions of the Act. The Tou may, therefore, mailer are as act include requirements for annual registration, listing of general controls provisions of also lieve 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 II your device is Classified (300 a00 ve) into ens affecting your device can be found in Title 21, additional Controls. Existing major regulations and the may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination costs of the other Flease of advised that I Dri- 3 issumed or a succe complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirem that FDA has made a determination that your as receined by other Federal agencies. You must of any Federal Statutes and regulations and uncluding, but not limited to: registration and listing (21 Comply with an all all the s requirements, and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse cvollas) (21 OF R OSS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your device to a locally marketing will allow you to begin narketing your active as useence of your device to a legally marketed notification. The FDA imanig of succiantal require 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 If you desire specific advice for your device of our incential (19). In the promotion 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 under the MDR regulation (2) CFR Pat 605), product go ...
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

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510(K) Number (if known): {{{ / 2,2 / 8 2

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

Indications for Use:

1717SGC 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_ (Part 21 CFR 801 Subpart D) AND/OR

(Part 21 CFR 807 Subpart C)

Over-The-Counter Use_

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

### Concurrence of CDRH, Office of Device Evaluation(ODE)


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Division of Radiological Devices

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