RAYSCAN A-EXPERT

K131693 · Ray Co., Ltd. · MUH · Nov 1, 2013 · Dental

Device Facts

Record IDK131693
Device NameRAYSCAN A-EXPERT
ApplicantRay Co., Ltd.
Product CodeMUH · Dental
Decision DateNov 1, 2013
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 872.1800
Device ClassClass 2

Intended Use

The RAYSCAN α- 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 α-Expert is a digital dental X-ray system for panoramic and optional cephalometric imaging. It uses an X-ray source and flat panel sensors (or CdTe direct flat panel for scan-type cephalometric) to capture images of teeth, jaw, and oral structures. The system includes optional 'SMARTDent' software for processing and archiving. Operated by dental professionals in clinical settings, the device produces digital radiographs to assist in diagnosing oral diseases. Modifications from the predicate include an additional scan-type cephalometric sensor and updated software protocols for segmentation, bitewing, and orthogonal imaging. The output is viewed by clinicians to inform dental treatment planning.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance testing, including software verification and validation, and expert review of image comparisons.

Technological Characteristics

Extraoral dental X-ray system; 60-90kVp voltage; 4-17mA current; 0.5mm focal size; 2.6mm Al equivalent filtration. Detectors: Flat panel X-ray sensor (Pano/One-shot Ceph) and CdTe direct flat panel sensor (Scan-type Ceph). Connectivity: Digital imaging with optional SMARTDent software. Standards: IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, 60601-1-2.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ # NOV 0 1 2013 K131693 Page 1 of 5 510(k) Submission- RAYSCAN a-Expert # Special 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/Manager<br>e-mail : yunjung.ha@raymedical.co.kr | ## Device Name Trade/Proprietary Name : RAYSCAN α – 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 RAYSCAN a-Expert (K122918) {1}------------------------------------------------ ## Description Modified RAYSCAN α- 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. The modifications are as following: - Hardware: Added option CEPH sensor (Scan type). In addition to the one-shot type CEPH sensor of original device (K122918), the modified device offers an additional Scan type CEPH sensor. - · Updated Software including: - Additional protocol for new CEPH sensor (Scan type): Lateral wide - Additional PANO protocols: Segmentation (Individual Tooth), Bitewing, and Orthogonal RAYSCAN α- Expert offers digital imaging with or without the optional One-shot type & Scan type cephalometric attachment. Detector Options: Base: RAYSCAN α-P: PANO Option: RAYSCAN α-OC: PANO+One-shot CEPH Option: RAYSCAN α-SC: PANO+SCAN CEPH The system includes processing, and archiving "SMARTDent "software(Optional) #### Indication for use The RAYSCAN α- 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. {2}------------------------------------------------ ﺎ ﺳ | Parameter | RAYSCAN α-Expert<br>[Modified] | RAYSCANα-Expert<br>[K122918] | Remarks | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Common Name | Dental panoramic and<br>cephalometric X-ray system | Dental panoramic and<br>cephalometric X-ray system | Same | | Indications<br>for use | The RAYSCAN α- Expert Dental<br>X-Ray System is an extraoral<br>source dental panoramic and<br>optional cephalometric X-ray<br>system intended to produce<br>X-rays for dental radiographic<br>examination and diagnosis of<br>diseases of the teeth, jaw,<br>and oral structures. | The RAYSCAN α- Expert Dental<br>X-Ray System is an extraoral<br>source dental panoramic and<br>optional cephalometric X-ray<br>system intended to produce<br>X-rays for dental radiographic<br>examination and diagnosis of<br>diseases of the teeth, jaw, and<br>oral structures. | Same | | Performance<br>Specification | Panoramic<br>Cephalometric(optional)<br>- One_shot type<br>- Scan type | Panoramic<br>Cephalometric(optional)<br>-One_shot type | Additional<br>Scan type<br>Cephalometric<br>(Optional) | | Detector type | α-OC<br>: PANO+One-shot CEPH(option)<br>α -P : PANO<br>α -SC: PANO+SCAN CEPH(option) | α-OC<br>:PANO+One-shotCEPH(option)<br>α -P: PANO | Additional<br>Scan type<br>Cephalometric<br>(Optional) | | Detector<br>Type | Pano: Flat panel X-ray sensor<br>Ceph(Optional)<br>- Flat panel X-ray sensor<br>[One-shot type]<br>- CdTe Direct flat panel<br>sensor[Scan type] | Pano: Flat panel X-ray sensor<br>Ceph(Optional)<br>- Flat panel X-ray sensor | Additional<br>Scan type<br>Cephalometric<br>(Optional) | | Focal size | 0.5mm | 0.5mm | Same | | X-ray Voltage | 60~90kVp | 60~90kVp | Same | | X-ray Current | 4~17mA | 4~17mA | Same | | Total Filtration | 2.6 mm Al equivalent | 2.6 mm Al equivalent | Same | | Magnification | Pano : 1.31<br>Ceph[One-shot type] : 1.13 | Pano : 1.31<br>Ceph[One-shot type] : 1.13 | Same | | | Ceph[Scan type] : 1.11 | | Additional<br>specification<br>of Scan type<br>Cephalometric<br>(Optional) | | Scan time | Pano : 14sec | Pano : 14sec | Same | | | Ceph[One-shot type] : | Ceph | Same | | | 0.3sec~3.0sec | : 0.3sec~3.0sec | | | | Ceph[Scan type] : below 18sec | | Additional<br>specification<br>of Scan type<br>Cephalometric<br>(Optional) | | Applicable<br>Standards | IEC 60601-1 | IEC 60601-1 | Same | | | IEC 60601-1-1 | IEC 60601-1-1 | | | | IEC 60601-1-3 | IEC 60601-1-3 | | | | IEC 60601-2-7 | IEC 60601-2-7 | | | | IEC 60601-2-28 | IEC 60601-2-28 | | | | IEC 60601-2-32 | IEC 60601-2-32 | | | | IEC 60601-1-2 | IEC 60601-1-2 | | | Certificate<br>Product | CE0120(MDD93/42/EEC) | CE0120(MDD93/42/EEC) | Same | # Statement of Substantial Equivalence · ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 3 / 5 . {3}------------------------------------------------ #### 510(k) Submission- RAYSCAN a-Expert Safety details, for instance the non-clinical performance, in regards to intended use, safety characteristics, PANORAMA sensor (Detector) and One-shot CEPH sensor(Detector) are equivalent. The only difference is the additional option of Scan type CEPH sensor. The safety & effectiveness reports for the added Scan type cephalometric sensor is provided separately. Remaining sensors are the same, the non-clinical considerations thereof are also equivalent, and the report regarding non-clinical & clinical consideration for the added Scan CEPH sensor is provided separately. 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. Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, new RAYSCAN α-Expert is substantially equivalent, in terms of safety and effectiveness, with RAYSCAN α- Expert[K122918]. 4 / 5 {4}------------------------------------------------ 510(k) Submission- RAYSCAN a-Ex K131693 Page 5 of 5 ### Safety and Effectiveness Information Software verification testing and validation testing was performed to confirm that the modified device performed as intended and that changes made to the hardware and software had no adverse impact on the functionality of the system. All tests met requirements demonstrating that the modified device performed as expected. 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 and IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with the standard IEC 60601-1-2. Non-clinical & Clinical considerations according to FDA Guidance "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 &-Expert system are safe and effective to perform its intended use as well as substantially equivalent to the predicate device {5}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized emblem of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem. The text is in all capital letters and is in a sans-serif font. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 1, 2013 Ray Co., Ltd. % Mr. Andrew Paeng Consultant 4747 Hoen Avenue SANTA ROSA CA 95405 Re: K131693 Trade/Device Name: RAYSCAN a-Expert Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 1. 2013 Received: October 11, 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 device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set {6}------------------------------------------------ Page 2 - Mr. Andrew 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. 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.goy/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/Industrv/default.htm. Sincerely yours. Mekael D. D'Hara 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 K131693 510(k) Number (if known): Device Name: RAYSCAN α-Expert Indications For Use: The RAYSCAN α- 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 AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Michael D. O'Hara (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiolgical Health Page 1 of 510(k) ======================================================================================================================================================================= K131693
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