RAYSCAN A-EXPERT 3D

{0}------------------------------------------------ MAR 1 2 2013 K122981 page 1 of 5 510(k) Submission- RAYSCAN a-Expert 3D # 510(k) Summary The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92. Date: | APPLICANT | RAY Co.,Ltd | |----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ADDRESS | #362-43 (218 Maeyoung St.) 3rd & 4th Floor,<br>Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, Korea | | Manufacturer | RAY Co.,Ltd<br>#362-43 (218 Maeyoung St.) 3rd & 4th Floor,<br>Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, Korea<br>TEL : +82-31-605-1000<br>FAX : +82-2-6280-5534 | | Contact Person | Yun Jung. HA<br>e-mail : yunjung.ha@raymedical.co.kr | ## Device Name Trade/Proprietary Name : RAYSCAN α-Expert 3D Common Name: Dental panoramic/tomography and cephalometric x-ray system ### Classification x-ray, tomography, computed, dental (21 CFR 892.1750) Class : Il Product code : OAS Panel : Radiology #### Predicate device Rotagraph EVO 3D(K111152) {1}------------------------------------------------ K122981 Page 2 of 5 510(k) Submission- RAYSCAN a-Expert 3D ## Description RAYSCAN a-Expert 3D is a 3D computed tomography for scanning hard tissues such as bones and teeth. By rotating the c-arm which includes the high voltage generator all-in-one x-ray tube and a detector on each end, CBCT image of whole dentomaxillofacial is attained by recombining data from the same level that are scanned from different angles. Panoramic image scanning function for attaining images of the entire teeth and cephalometric scanning option for attaining the cephalic images are included. The system includes processing, and archiving "SMARTDent "software(Optional) #### Indication for use RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dento-maxillo-facial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam technique. "CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals." | Parameter | RAYSCAN α-Expert 3D<br>RAY Co.,Ltd | Rotograph EVO 3D<br>K111152 | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common<br>Name<br>Indications<br>for use | Dental panoramic/tomography and<br>cephalometric x-ray system<br>RAYSCAN α-Expert 3D, panoramic x-ray<br>imaging system with cephalostat, is an<br>extraoral source x-ray system, which is<br>intended for dental radiographic<br>examination of the teeth, jaw, and oral<br>structures, specifically for panoramic<br>examinations and implantology and for<br>TMJ studies and cephalometry, and it has<br>the capability, using the CBVT technique,<br>to generate dento-maxillo-facial 3D<br>images.<br>The device uses cone shaped x-ray beam<br>projected on to a flat panel detector, and<br>the examined volume image is<br>reconstructed to be viewed in 3D viewing<br>stations.2D Images are obtained using<br>the standard narrow beam technique.<br>"CAUTION: Federal (US) law<br>restricts the sale of this device to,<br>or on the order of, licensed<br>professionals." | Dental panoramic/tomography and<br>cephalometric x-ray system<br>Rotograph EVO 3D, panoramic x-ray<br>imaging system with cephalostat, is an<br>extraoral source x-ray system, which is<br>intended for dental radiographic<br>examination of the teeth, jaw, and oral<br>structures, specifically for panoramic<br>examinations and implantology and for<br>TMJ studies and cephalometry, and it<br>has the capability, using the CBVT<br>technique, to generate<br>dentomaxillofacial 3D images.<br>The device uses cone shaped x-ray<br>beam projected on to a flat panel<br>detector, and the examined volume<br>image is reconstructed to be viewed in<br>3D viewing stations. 2D Images are<br>obtained using the standard narrow<br>beam technique.<br>The device is to be operated and used<br>by dentists, radiologists and other | | | | legally qualified health care<br>professionals. | | | | | ## Statement of Substantial Equivalence {2}------------------------------------------------ K122981 page 3 of 5 510(k) Submission- RAYSCAN α--Expert 3D | Mode of<br>Operation | | Continuous operation with<br>intermittent, stated permissible<br>loading | Continuous operation with<br>intermittent load | | |------------------------------|-------|--------------------------------------------------------------------------|------------------------------------------------|----------------------| | | | CBCT Cone beam Computed | CBCT Cone beam Computed | | | 3D technology | | Tomography | Tomography | | | | | CBCT Computed tomography | CBCT Computed tomography | | | Performance<br>Specification | | Panoramic | Panoramic | | | | | Cephalometric(optional) | Cephalostic(optional) | | | | | | Full Dentition | | | | | Standard | | | | | | Implant | Left Jaws | | | | CT | Surgical guide | | | | | | Endo<br>Sinus | Right Jaws | | | | | TMJ | | | | | | | Sinus<br>Adult Panoramic | | | | | Normal | Child Panoramic | | | | PANO | TMJ | Open-closed mouth lateral TMJ | | | Exam | | Sinus | P-A Sinus (rotational) | | | mode | | PA,AP | | | | | | Lateral | Lateral Ceph | | | | Ceph | SMV | A-P and P-A Ceph | | | | | Carpus | Carpus (hand) | | | | | Reverse Town's<br>Waters | | | | | | | Half Panoramic adult | | | | | | Half Panoramic child | | | | Other | | Orthogonal Projection | | | | | | Low Dose Panoramic | | | | | Computed Tomography(CT) : | Frontal Dentition<br>Computed Tomography(CT) : | | | Detector | | Flat panel X-ray sensor | Flat panel X-ray sensor | | | Type | | Pano : Flat panel X-ray sensor | Pano : Flat panel X-ray sensor | | | | | Ceph : Flat panel X-ray sensor | Ceph : CCD Sensor | | | | | Ceph Apparatus | Ceph Apparatus | | | | | Vertical Carriage | Vertical Carriage | | | | | Rotator | Rotator | | | | | X-RAY Generator | X-ray Generator | | | | | X-ray tube | X-ray tube | | | | | High Frequency Generator | High Frequency Generator | | | Main | | Column | Column | | | Components | | Touch monitor (panal) | Keyboard | | | | | Detector(CT/Panoramic, | Detector(CT/Panoramic, | | | | | Cephalometric) | Cephalometric) | | | | | Chinrest<br>Head rest | Chinrest<br>Head rest | | | | | Automatic Collimator | Collimator | | | | | Exposure switch | Exposure switch | | | | | Emergency stop switch | Emergency stop switch | | | | | | CT exams | CT exams(Volumetric) | | Automatic | | Panoramic exams | Panoramic exams | | | Collimator | | | Cephalometric exams | Cephalometric exams | . · {3}------------------------------------------------ K122981 Page 4 of 5 510(k) Submission- RAYSCAN a-Expert 3D . | | | Bite stick | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | | Bite block<br>Chinrest(Patient support of the<br>stand type) | Chinrest<br>(Patient support of the stand<br>type) | | | Chinrest(TMJ, Sinus and etc.) | Head rest | | | Head rest | X-ray push button with extensible<br>cable | | Accessories | X-ray push button with<br>extensible cable | Disposable byte protective<br>sleeves | | | Disposable byte protective<br>sleeves | 10ear centring pins for ceph | | | Remote controller | 10 disposable head strips for 3D<br>exams | | Display Type | TFT LCD type(Normally black)<br>*1280x800 pixel | Alphanumeric"OLED"Display of<br>2 lines of 20 characters | | | Touch monitor (panel). | Alpanumeric "OLED" Display. | | | Exposure button. | x-ray push button with extensible<br>cable. | | | Operating PC screen. | Operating PC screen. | | | Every operation is guided by<br>messages shown on the display. | Every operation is guided by<br>messages shown on the display. | | | Selectable language : English | Selectable languages : Italian,<br>English, French, Spanish, German,<br>Turkish, Portuguese, Dutch. | | | Operation S/W-<br>RayScan(Workstation) | Operation S/W(Workstation) | | Rated power | 110-240 V~, 50 / 60 Hz, 2.5kVA | 110-120/220-240V~,50/60Hz,1.5 kVA | | Class | Class I with type B applied parts<br>according to IEC 60601-1 | Class I with type B applied parts<br>according to IEC 60601-1 | | Focal size | 0.5mm | 0.5mm | | Field of<br>View(CT) | 90x90mm | 85x85mm | | X-ray Voltage | 60~90kVp | 60~86kVp | | X-ray Current | 4~17mA | 6~12 mA | | Total Filtration | 2.6 mm Al equivalent | 2.5 mm Al equivalent | | Detector Pixel<br>size | Computed Tomography(CT) : 100 μm<br>Pano : 100 μm<br>Ceph : 150 μm | Computed Tomography(CT) : 127 μm<br>Pano : 127 μm<br>Ceph : 48 μm | | | | CT<br>Open/close mouth TMJ : 1.25 | | Magnification | CT : 1.39<br>Pano : 1.31<br>Ceph : 1.13 | Sinus : 1.27<br>Pano : 1.28<br>Ceph : 1.10 in the mid-sagittal plane in<br>LL projection | | Scan time | CT : 14sec<br>Pano : 14sec<br>Ceph : 0.3sec~3.0sec | CT : Max 20sec<br>Pano : Max 13.8sec<br>Ceph : 15sec | | Grey level | CT : 14bit<br>Pano : 14bit<br>Ceph : 14bit | CT : 14bit<br>Pano : 14bit<br>Ceph : 12bit | | Format<br>compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | | Image acquisition | Giga-Ethernet Network | Giga-Ethernet Network | | Rotation angle | 360° | 200° | | | | | | PC technical<br>specifications | - OS : Windows 7, 32Bit<br>- CPU : Intel Dual core and over<br>- RAM : 4GB and over<br>- HDD : 250GB and over<br>- Network : Gigabit Ethernet<br>- Resolution : 1366x768 and over | - OS : Windows 7, 32Bit<br>- CPU: Intel® Core™ i5-750<br>- RAM: 4GB<br>- HDD: 1TB<br>- Network : Gigabit Ethernet<br>- Resolution : 1440x900 | | Total Height | Max 2,296mm | Max 2,450mm | | Weight | Computed Tomography(CT)+<br>Panoramic<br>: 148kg(326lb)<br>Computed Tomography(CT)+<br>Panoramic+Cephalostic(optional)<br>: 165kg(363lb) | Computed Tomography(CT)+<br>Panoramic<br>: 161kg(354lb)<br>Computed Tomography(CT)+<br>Panoramic<br>+Cephalostic(optional)<br>: 186kg(409lb) | | 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 60601-2-44<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 60601-2-44<br>IEC 60601-1-2 | | Certificate<br>Product | CE0120(MDD93/42/EEC) | CE0051(MDD93/42/EEC), FDA | {4}------------------------------------------------ K122981) Page 5 of 5 510(k) Submission- RAYSCAN a-Expert 3D RAYSCAN a-Expert 3D has 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 device. ### Safety and Effectiveness Information Electrical, mechanical, environmental safety and performance testing according to standards IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 and IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with the 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, constructions, construction materials, principal of Operation, features and technical data, the RAYSCAN α-Expert 3D system are safe and effective to perform its intended use as well as substantially equivalent to the predicate device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 12, 2013 Ray, Co., Ltd. % Mr. Andrew Paeng Consultant 8920 Wilshire Blvd., Suite 603 BEVERLY HILLS CA 90211 Re: K122981 Trade/Device Name: RAYSCAN a-Expert 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS 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, 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 {6}------------------------------------------------ Page 2 - Mr. Paeng 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. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, \$\left(m\right)\$ for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: RAYSCAN a-Expert 3D Indications For Use: RAYSCAN α - Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dentomaxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam technique. AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (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) sinh.7) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510 (k) : Page 1 of ﻢ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ