RAYSCAN A-EXPERT

K122918 · Ray Co., Ltd. · MUH · Mar 15, 2013 · Dental

Device Facts

• Record ID: K122918
• Device Name: RAYSCAN A-EXPERT
• Applicant: Ray Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Mar 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Story

RAYSCAN a-Expert is an extraoral dental X-ray system for panoramic and optional cephalometric imaging. Device uses X-ray generator and tube to produce X-ray beams; flat panel sensors capture digital images of teeth, jaw, and oral structures. Operated by dental professionals in clinical settings; patient positioned via chinrest/headrest. System includes touch monitor control panel; optional SMARTDent software for image processing and archiving. Output consists of digital radiographic images used by clinicians for diagnostic assessment of oral pathologies. Device supports standing or wheelchair-bound patients; features automatic collimator, emergency stop, and remote control options. Benefits include high-resolution digital diagnostic imaging for dental treatment planning.

Clinical Evidence

Bench testing only. Performance evaluated per FDA guidance for Solid State X-ray Imaging Devices. Testing included electrical, mechanical, and environmental safety (IEC 60601-1, 1-1, 1-3, 2-7, 2-28, 2-32) and EMC (IEC 60601-1-2). All results were satisfactory.

Technological Characteristics

Extraoral dental X-ray system; high-frequency generator; 0.5mm focal size; 60-90kVp voltage; 4-17mA current; 2.6mm Al equivalent filtration. Digital imaging via flat panel X-ray sensors. Connectivity via DICOM 3.0. Class I with type B applied parts. Wall or floor mount. Touch monitor interface.

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures in patients requiring extraoral panoramic or cephalometric imaging.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Orthophos XG 105 DS/Ceph Dental X-ray system (K033073)

Submission Summary (Full Text)

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MAR 1 5 2013

K122968
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510(k) Submission- RAYSCAN a - Expert

## 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:

| APPLICANT | RAY Co.,Ltd |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADDRESS | #362-43 (218 Maeyoung Rd.) 3rd & 4th Floor,<br>Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, Korea |
| Manufacturer | RAY Co., Ltd<br>#362-43 (218 Maeyoung Rd.) 3rd & 4th Floor,<br>Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, Korea<br>TEL : [phone]<br>FAX : [phone] |
| Contact Person | Yun-Jung HA<br>e-mail : [e-mail]<br>TEL : [phone]<br>FAX : [phone] |

### Device Name

Trade/Proprietary Name : RAYSCAN a - Expert Common Name: Dental panoramic and cephalometric X-ray system

### Classification

Extraoral source dental X-ray system (21 CFR 872.1800 ) Class : II Product code : MUH Panel : Radiology

### Predicate device

Orthophos XG 105 DS/Ceph Dental X-ray system(K033073)

#### Description

RAYSCAN a- Expert is designed for panoramic scanning of teeth, jaw and oral cavity, used to create and control the X-ray beam. And as a dental digital panoramic X-ray system with X-ray located on outer part of the oral cavity, includes the Cephalometric scanning function, as an option, for acquiring images of the head.

RAYSCAN a- Expert offers digital imaging with or without the optional cephalometric attachment. The system includes processing, and archiving "SMARTDent "software(Optional)

#### Indication for use

The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

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KI22918
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## Statement of Substantial Equivalence

| | Parameter | RAYSCAN α-Expert<br>RAY Co.,Ltd | Orthophos XGPlus DS/Ceph<br>K033073 |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common name | Dental panoramic and<br>cephalometric X-ray system | Dental panoramic and cephalometric X-<br>ray system |
| | Indication for use | The RAYSCAN α- Expert Dental X-Ray<br>System is an extraoral source dental<br>panoramic and optional cephalometric<br>X-ray system intended to produce X-rays<br>for dental radiographic examination and<br>diagnosis of diseases of the teeth, jaw, and<br>oral structures. | The Orthophos XGPlus DS/Ceph Dental X-<br>Ray System is an extraoral source dental<br>panoramic and optional cephalometric X-<br>ray system intended to produce X-rays for<br>dental radiographic examination<br>and<br>diagnosis of diseases of the teeth, jaw,<br>and oral structures. |
| | Mode of<br>Operation | Continuous operation with<br>intermittent,<br>stated permissible loading | Continuous operation with<br>intermittent load |
| | Performance<br>Specification | Panoramic<br>Cephalometric(optional) | Panoramic<br>Cephalometric(optional) |
| | Imaging modality | Digital only | Digital only |
| Exam<br>mode | PANO | Normal<br>Pedodontics<br>TMJ<br>Sinus | Standard panorama<br>Standard panorama without ascending<br>branches<br>Pediatric program<br>Lateral<br>Axial<br>Sinus<br>Program for posterior teeth |
| | Ceph | PA, AP<br>Lateral<br>SMV<br>Carpus<br>Reverse Town's<br>Waters | PA<br>AP<br>Carpus |
| | Optional | | TSA(Transversal layers based on wide-<br>beam tomography) |
| | Detector<br>Type | Pano : Flat panel X-ray sensor<br>Ceph : Flat panel X-ray sensor | Pano : CCD X-ray sensor<br>Ceph : CCD X-ray sensor |
| | Control Panel | Touch monitor(Panel) | Easy Pad(Touch type) |
| | Main Component | Ceph Apparatus<br>Vertical Carriage<br>Rotator<br>X-RAY Generator<br>X-ray tube<br>High Frequency Generator<br>Column | Ceph Apparatus<br>Vertical Carriage<br>Rotator<br>X-ray Generator<br>X-ray tube<br>High Frequency Generator<br>Column |
| | | Touch monitor (panel) | Easy Pad (Touch type) |
| | | | |
| | Detector(Panoramic,<br>Cephalometric) | Detector(Panoramic,<br>Cephalometric) | |
| | Chinrest | Chinrest | |
| | Head rest | Head rest | |
| | Automatic Collimator | Collimator | |
| | Exposure switch | Exposure switch | |
| | Emergency stop switch | Emergency stop switch | |
| Automatic<br>Collimator | Yes | Yes | |
| | Bite block | Bite block | |
| Accessories | Chinrest(Patient support of the<br>stand type)<br>Chinrest(TMJ, Sinus and etc:) | Chinrest<br>(Patient support of the stand type) | |
| | Head rest | Head rest<br>(included temple support) | |
| | X-ray push button with<br>extensible cable | X-ray push button | |
| | Earload | Earplugs with holders | |
| | Nasal bar | Nose support | |
| | Remote controller(Optional) | Remote controller(Optional) | |
| Rated power | 110-240 V~, 50 / 60 Hz, 2.3kVA | 100-120 V, 220-240 V, 50/60Hz,<br>2.8kW | |
| | Class I with type B applied parts | Class I with type B applied parts | |
| Class | according to IEC 60601-1 | according to IEC 60601-1 | |
| Focal size | 0.5mm | 0.5mm | |
| X-ray Voltage | 60~90kVp | 60~90kVp | |
| X-ray Current | 4~17mA | 3~16mA | |
| Total Filtration | 2.6 mm Al equivalent | 2.5 mm Al equivalent | |
| Detector Pixel | Pano : 100 μm | Pano : 27 μm | |
| size | Ceph : 150 μm | Ceph : 27 μm | |
| Magnification | Pano : 1.31 | Pano : 1.25 | |
| | Ceph : 1.13 | Ceph : 1.25 | |
| | | Pano : 14.2sec | |
| Scan time | Pano : 14sec | Pano(Quickshot) : 9.1sec | |
| | Ceph : 0.3sec-3sec | Ceph : 9.14sec | |
| | | Ceph(Quickshot) : 4.7sec | |
| Format<br>compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | |
| PC technical<br>Specifications<br>(Requirements<br>for PC system) | - OS : Windows 7, 32Bit<br>- CPU : Intel Dual core and over<br>- RAM : 4GB and over<br>- HDD : 500GB and over<br>- Network : Gigabit Ethernet<br>- Display : 32 bit color display<br>- Resolution : 1366x768 and over | - OS : Windows 2000 Workstation ,<br>Windows XP Professional Workstation<br>or Vista<br>- RAM min. 256 MB<br>- HDD: > 4 GB/database<br>- > 50 MB/SIDEXIS installation<br>- Network : 10/100 MBit Ethernet<br>- Resolution : 1024x768 and over | |
| Dimension | Panoramic<br>: 1,118mm x 1,481mm x 2,296mm<br>(WxDxH)<br>Panoramic +Cephalostic (optional)<br>: 1,672mmx 1,481mm x 2,296mm<br>(WxDxH) | Panoramic<br>: 1,042mm x 1,371mm x 2,249mm<br>(WxDxH)<br>Panoramic+Cephalostic(optional)<br>: 1,955mm x 1,371mm x 2,249mm<br>(WxDxH) | |
| Weight | Panoramic<br>: 147kg(324lb)<br>Panoramic+Cephalostic(optional)<br>: 164kg(361lb) | Panoramic<br>: 120kg(264lb)<br>Panoramic+Cephalostic(optional)<br>: 141kg(310lb) | |
| Type of<br>installation | Wall or floor mount | Wall or floor mount | |
| Patient position | Standing / Wheelchair | Standing / Wheelchair | |
| Applicable<br>Standards | IEC 60601-1<br>IEC 60601-1-1<br>IEC 60601-1-3<br>IEC 60601-2-7<br>IEC 60601-2-28<br>IEC 60601-2-32<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-1<br>IEC 60601-1-3<br>IEC 60601-2-7<br>IEC 60601-2-28<br>IEC 60601-2-32<br>IEC 60601-1-2 | |
| Certificate<br>Product | CE0120(MDD93/42/EEC) | CE0086(MDD93/42/EEC), FDA,SFDA | |

·

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K122918
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510(k) Submission - RAYSCAN a - Expert

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K1229.18
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510(k) Submission- RAYSCAN a - Expert

RAYSCAN a- Expert have the same indication for use as the predicate devices, It shares the same technological characteristics as the predicate devices, Minor technological differences do not raise any new questions regarding safety or effectiveness of the devices.

#### Safety and Effectiveness Information

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Non-clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.

All test results were satisfactory.

#### Conclusions

Based on a comparison of intended use, indications, construction materials, principal of Operation, features and technical data, the RAYSCAN a- Expert system is safe and effective to perform its intended use as well as substantially equivalent to the Predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting three abstract shapes, possibly representing people or services.

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

March 15, 2013

Ray, Co., Ltd. % Mr. Andrew Paeng Consultant 8920 Wilshire Blvd., Suite 603 BEVERLY HILLS CA 90211

Re: K122918

Trade/Device Name: RAYSCAN α-Expert Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: January 14, 2013 Received: February 06, 2013

Dear Mr. Paeng:

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. Iisting 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

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Page 2 - Mr. Paeng

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.

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,

Smh7)

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): K122918

Device Name: RAYSCAN a- Expert

Indications for Use:

The RAYSCAN «- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

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)


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

K122918 510(k)

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