RAYSCAN A-EXPERT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002 April 22, 2015 Ray Co., Ltd. % Mr. Andrew Paeng Consultant 4747 Hoen Avenue SANTA ROSA CA 95405 Re: K142058 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: March 20, 2015 Received: March 23, 2015 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 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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, Robert A Ochs Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K142058 Device Name RAYSCAN a-Expert Indications for Use (Describe) The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric Xray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | <span> <span style="text-decoration:line-through;"></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 5. 510(K) Summary {4}------------------------------------------------ # 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 | #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823,<br>Korea | | Manufacturer | RAY Co.,Ltd<br>332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823,<br>Korea | | | TEL : +82-31-605-1000<br>FAX : +82-2-6280-5534 | | Contact Person | Kyungha Seo<br>e-mail : Kyungha.seo@raymedical.co.kr | ### Device Name Trade/Proprietary Name: RAYSCAN α–Expert Common Name: Dental panoramic and cephalometric X-ray system # Classification Classification Name: Extraoral source x-ray system Regulatory Number: 21 CFR 872.1800 Product Code: MUH Device Class: II Review Panel: Radiology {5}------------------------------------------------ | Parameter | Predicated Device-1 | Predicated Device-2 | |----------------------|-------------------------------|-------------------------------| | Device Name | RAYSCAN α-Expert | RAYSCAN α-Expert | | Manufacturer | RAY Co., Ltd | RAY Co., Ltd | | 510(K) Number | K122918<br>Traditional 510k | K131693<br>Special 510k | | Classification name | Extraoral source x-ray system | Extraoral source x-ray system | | Regulation number | 872.1800 | 872.1800 | | Primary product code | MUH | MUH | #### Predicate device #### Description RAYSCAN α-OC, SC, OCS, and OCL are 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 α- Expert offers digital imaging with or without the optional One-shot type & Scan type cephalometric attachment. Detector Options: Specific models according to the detector type; Pano and Ceph mounted in the RAYSCAN α- Expert system are classified as shown below. RAYSCAN α-P: PANO(model-C10500D) RAYSCAN α-SC: PANO(model-C10500D)+Scan Ceph(model-XID-C24DS) RAYSCAN α-ΟCL: PANO(model-C10500D)+One shot ceph(model-PaxScan 4336X) RAYSCAN α-ΟCS: PANO(model-C10500D)+One shot ceph(model-PaxScan 2530C) Non-clinical & clinical consideration report for all types of Detectors included in the Ray Co.,Ltd Page 3 of 17 {6}------------------------------------------------ RAYSCAN α- Expert system are prepared in compliance with 21CFR807.92(a)(7) of the FDA. The Detector model mounted in our Dental X-ray system RAYSCAN α-OCL [One shot Ceph] is the PaxScan 4336X model. The Non-clinical report provided by Varian, manufacturer of the Detector, was submitted in place of the Non-clinical report regarding the Solid state Detectors required by FDA. The Non-clinical report provided by the manufacturer Varian includes and describes the Non-Clinical Data for both models PaxScan 4336W and PaxScan 4336WX. In particular the PaxScan 4336W model includes a wireless detector function however PaxScan 4336X, the detector mounted in our RAYSCAN α-OCL [One shot Ceph] system is a detector without the wireless function, therefore the data for wireless function is not attached. SMARTDent software for processing and archiving is 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. Caution: Federal law restricts this device to sale by or on the order of a dentist. #### Patient population The patient population can be the possible person who can be taken X-ray diagnostic radiation exposure. There is no restriction for ethnic group, Gender, weight, health, or condition. We recommend patients for x-ray diagnostic radiation exposure to be over 5 years old. #### Device functions {7}------------------------------------------------ The purpose of this unit is diagnose clinical structures of a tooth and head areas mainly by using the characteristics of permeability from X-ray. The principle of functioning and formations are as following. The machine is made of X-ray generator and arms in which transfers X-ray signals to a sensor in 2D. Also, an object that has a magnification is required in a distance. Moreover, the unit has to be adjustable depending on height of a patient and PC system to reconstruct an image The arm parts are controlled for rotating and linear moving to synchronize between the sensor and X-ray generator to get the image of interests. The purpose of this mechanism is to provide the images as preferred to diagnose in a monitor. Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 2 functions could be in 1 system, or Panorama only system depending on the needs. To provide the features as mentioned above, digital transferring from permeated X-ray to absorbing to the sensor is essential and all the process are proceed in Detector. Detector transfers X-ray to light depending on the structure materials. Detector is separated into indirect method that the light is changed to digital signals on photodiode and direct method in which the light is directly transferred to digital signal. This unit is using both direct and indirect method depending on the interior structure materials. #### Operating principle of the detector X-ray data entered into the detector from an outside source is converted to visible ray by detector's Scintillator and The visible ray is transferred to CMOS ASIC and converted to an Electric signal to form an image signal. Then the signal is changed to a Digital form and through the high speed LAN cable, the acquired image data is transmitted to the PC. Acquired resulting image is displayed on the monitor by the PC Software. #### Comparison of the detector One shot ceph detector installed on the One shot ceph option RAYSCAN α-OC in Predicate devices RAYSCAN α-Expert[K122918, Traditional] and RAYSCAN α-Expert[K131693, special] is SDX-4336CP (model name). Whereas the One shot Ceph type mounted in the proposed RAYSCAN α-Expert [K142058, Traditional] offers 2 models depending on the detector size. In RAYSCAN α-OCL, PaxScan 4336X(size: 42.4cm*35.3cm) detector is mounted and in {8}------------------------------------------------ RAYSCAN α-OCS, PaxScan 2530C(24.9cm*30.2cm) detector is installed. Meaning if One shot Ceph option is limited to RAYSCAN α-OC in the predicate devices RAYSCAN α–Expert [K122918, Traditional] and RAYSCAN α-Expert3D[K131693, special] then The One shot Ceph option for the proposed device RAYSCAN α-Expert[K142058, Traditional] offers 2 models RAYSCAN α-OCL and RAYSCAN α-OCS according to the detector size. The detector installed in the Predicate device RAYSCAN α-OC and Proposed devices RAYSCAN α-OCL and RAYSCAN α-OCS presents no differences in the technical principle and characteristics and only the manufacturer of the detector and part of the specification were changed. Differences in the detector SDX-4336CP installed in RAYSCAN α-OC of the Predicate device and detectors PaxScan 4336X and PaxScan 2530C mounted in the Proposed device models RAYSCAN α-OCL and RAYSCAN α-OCS are shown in the following table. The detector for 2 newly added models RAYSCAN α-OCL(PaxScan 4336X) and RAYSCAN α-OCS(PaxScan 2530C) share the same manufacturer as well as the same technical characteristics, only difference in the detector is its size. Detector in the RAYSCAN α-OCL(PaxScan 4336X) has the size 42.4 (V)cm x 35.3 (H) cm and size of the detector in RAYSCAN α-M3DS is 24.9(V)cm x 30.2(H)cm. In addition, among the detector option of the RAYSCAN α-Expert3D included in RAYSCAN α-Expert 3D[K122918, Traditional] and RAYSCAN α-Expert3D[K131693, special] of the Predicate device, basic(RAYSCAN α-P) and scan type(RAYSCAN α-SC) are completely identical. | Division | | Proposed Device | Predicate Device<br>#1 | Predicate Device<br>#2 | |--------------------------------------------------------|--------------------------|--------------------------------|----------------------------------------|----------------------------------------| | | | RAYSCAN α-Expert | RAYSCAN α-Expert | RAYSCAN α-<br>Expert | | | | K142058 | K122918 | K131693 | | | | RAY Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | | | | Traditional | Traditional | Special | | PANO<br>detector | Manufacturer | | Hamamatsu | | | | Model | | C10500D | | | | Scintillator<br>Material | Same as predicate<br>device #1 | CsI (Indirect type) | Same as predicate<br>device #1 | | | Total pixel area | | 6.0(W)x1512(H)mm | | | | Total pixel | | 60x1512 | | | | Pixel size | | 100um | | | | | | | | | | Limiting resolution | | 5.0lp/mm | | | | Power<br>supply/Main | | 5VDC / 1100mA | | | | MTF | | 70% at 1LP/mm | | | | DQE | | 0.5 at 1LP/mm | | | | Manufacturer | | N/A<br>(No attached Scan<br>Ceph) | i3System | | | Model | | | XID-C24DS | | | Scintillator<br>Material | | | CdTe (Direct type) | | | Total pixel area | | | 4.8(W)x240(H)mm | | Ceph<br>(Scan)<br>detector | Total pixel | Same as predicate<br>device #2 | | 48x2400 | | | Pixel size | | | 100um | | | Limiting resolution | | | 5.0lp/mm | | | Power<br>supply/Main | | | 5VDC / 2A | | | MTF | | | 75% at 1LP/mm | | | DQE | | | 0.88 at 1LP/mm | | | Manufacturer | Varian | | Samsung Mobile<br>Display | | | Model | PaxScan 4336X | | SDX-4336CP | | | Scintillator<br>Material | GADOX (Indirect<br>type) | | CsI (Indirect type) | | Ceph<br>(One<br>shot,<br>Large<br>Size)<br>detector | Total pixel area | 427(W)x356(H)mm | Same as predicate<br>device #1 | 43.2 x 36.0 cm | | | Total pixel | 3072x2560 | | 2880 x 2400 | | | Pixel size | 139um | | 150 um | | | Limiting resolution | 3.6lp/mm | | 3.3 lp/mm | | | Power<br>supply/Main | 100-240VAC, 47-<br>63Hz | | 100-240VAC,<br>50/60Hz | | | MTF | 54% at 1LP/mm | | 45% at 1LP/mm | | | DQE | 0.2 at 1LP/mm | | 0.41 at 1P/mm | | | Manufacturer | Varian | N/A<br>(No attached one shot<br>CEPH.) | N/A<br>(No attached one<br>shot CEPH.) | | | Model | PaxScan 2530C | | | | | Scintillator<br>Material | GADOX (Indirect<br>type) | | | | Ceph<br>(One<br>shot,<br>Standard<br>Size)<br>detector | Total pixel area | 302(W)x249(H)mm | | | | | Total pixel | 2176x1792 | | | | | Pixel size | 139um | | | | | Limiting resolution | 3.6lp/mm | | | | | Power<br>supply/Main | 100-240VAC, 47-<br>63Hz | | | | | MTF | 54% at 1LP/mm | | | | | DQE | 0.2 at 1LP/mm | | | {9}------------------------------------------------ {10}------------------------------------------------ | Division | Model | Manufacturer | Own 510(K)<br>number | System in which it was cleared<br>510(k) number. | |---------------|------------------|--------------|----------------------|--------------------------------------------------------------------------------------------------| | Pano | C10500D | Hamamatsu | No | 1) System name: RAYSCAN α-Expert3D<br>2) Manufacturer: RAY CO., LTD<br>3) 510(K) Number: K122981 | | Scan Ceph | XID-C24DS | i3System | No | 1) System name: RAYSCAN α-Expert3D<br>2) Manufacturer: RAY CO., LTD<br>3) 510(K) Number: K131695 | | One shot Ceph | PaxScan<br>4336X | Varian | No | 1) System name: Multix Fusion<br>2) Manufacturer: Siemens<br>3) 510(K) Number: K121513 | | One shot Ceph | PaxScan<br>2530C | Varian | No | 1) System name: Unknown<br>2) Manufacturer: Unknown<br>3) 510(K) Number: Unknown | Information for detector own 510(K) number or system in which it was cleared 510(K) number. {11}------------------------------------------------ # Statement of Substantial Equivalence | Parameter | Proposed Device | Predicated Device | Predicated Device | | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | | | Device name | RAYSCAN α-Expert | RAYSCAN α-Expert | RAYSCANα-Expert | | | 510(K)<br>Number | K142058<br>Traditional 510k | K122918<br>Traditional 510k | K131693<br>Special 510k | | | Common<br>Name | Dental panoramic and<br>cephalometric X-ray system | Dental panoramic and<br>cephalometric X-ray system | Dental panoramic and<br>cephalometric X-ray system | | | Indications<br>for use | The RAYSCAN α- Expert Dental X-Ray System is an<br>extraoral source dental panoramic and optional<br>cephalometric X-ray system intended to produce X-<br>rays for<br>dental radiographic examination and<br>diagnosis of diseases of the teeth, jaw, and oral<br>structures. | The RAYSCAN α- Expert Dental X-Ray System is an<br>extraoral source dental panoramic and optional<br>cephalometric X-ray system intended to produce X-rays for dental radiographic examination and<br>diagnosis of diseases of the teeth, jaw, and oral<br>structures. | The RAYSCAN α- Expert Dental X-Ray System is an<br>extraoral source dental panoramic and optional<br>cephalometric X-ray system intended to produce X-<br>rays for dental radiographic examination and<br>diagnosis of diseases of the teeth, jaw, and oral<br>structures. | | | Mode of<br>Operation | Continuous operation with<br>intermittent, stated permissible<br>loading | Continuous operation with<br>intermittent, stated permissible<br>loading | Continuous operation with<br>intermittent, stated permissible<br>loading | | | Performance<br>Specification | 1) Panoramic<br>2) Cephalometric(optional)<br>- One shot type<br>- Scan type | 1) Panoramic<br>2) Cephalometric(optional)<br>- One shot type | 1) Panoramic<br>2) Cephalometric(optional)<br>- One shot type<br>- Scan type | | | Functional<br>Option | | Base<br>RAYSCAN α-P :<br>PANO<br>Option(CEPH)<br>RAYSCAN α-SC:<br>PANO + SCAN CEPH<br>RAYSCAN α-OCS:<br>PANO + One shot(9.8 X 11.9 inch)<br>RAYSCAN α-OCL:<br>PANO + One shot(16.8 X 14.0 inch) | Base<br>RAYSCAN α-P :<br>PANO<br>Option(CEPH)<br>RAYSCAN α-OC:<br>PANO + One shot | Base<br>RAYSCAN α-P :<br>PANO<br>Option(CEPH)<br>RAYSCAN α-SC:<br>PANO + SCAN CEPH<br>RAYSCAN α-OC:<br>PANO + One shot | | Exam | PAN<br>O | Standard(Normal)<br>TMJ<br>Sinus<br>Segmentation (Individual Tooth)<br>Bitewing<br>Orthogonal | Standard (Normal)<br>TMJ<br>Sinus | Standard(Normal)<br>TMJ<br>Sinus<br>Segmentation (Individual Tooth)<br>Bitewing<br>Orthogonal | | mode | Ceph<br>(Opti<br>onal) | Posterior/Anterior<br>Lateral<br>SMV<br>Carpus<br>Reverse Town's<br>Waters<br>Lateral wide | Posterior/Anterior<br>Lateral<br>SMV<br>Carpus<br>Reverse Town's<br>Waters | Posterior/Anterior<br>Lateral<br>SMV<br>Carpus<br>Reverse Town's<br>Waters<br>Lateral wide | | | 1) Pano: | 1) Pano: | 1) Pano: | | | | Flat panel X-ray sensor | Flat panel X-ray sensor | Flat panel X-ray sensor | | | Detector<br>Type | 2) Ceph(Option):<br>- Scan type: CdTe Direct flat panel sensor<br>- One shot type: Amorphous Silicon | 2) Ceph(Option):<br>- One shot type: Flat panel X-ray sensor | 2) Ceph(Option):<br>- Scan type: CdTe Direct flat panel sensor<br>- One shot type: Flat panel X-ray sensor | | | Exposure<br>switch<br>Type | "Deadman" Button type | "Deadman" Button type | "Deadman" Button type | | | | Ceph Apparatus | Ceph Apparatus | Ceph Apparatus | | | | Vertical Carriage | Vertical Carriage | Vertical Carriage | | | | Rotator | Rotator | Rotator | | | Main<br>Components | X-RAY Generator | X-RAY Generator | X-RAY Generator | | | | X-ray tube | X-ray tube | X-ray tube | | | | High Frequency Generator | High Frequency Generator | High Frequency Generator | | | | Column | Column | Column | | | | Touch monitor (panel) | Touch monitor (panel) | Touch monitor (panel) | | | | Detector | Detector | Detector | | | | - Panoramic | - Panoramic | - Panoramic | | | | - Scan type Cephalometric | - One shot type Cephalometric | - Scan type Cephalometric | | | | - One shot type Cephalometric: | | - One shot type Cephalometric | | | | 24.9(V) x 30.2(H) cm | | | | | | One shot type Cephalometric: | | | | | | 42.4 (V) x 35.3 (H) cm | | | | | | Chinrest | Chinrest | Chinrest | | | | Head rest | Head rest | Head rest | | | | Automatic Collimator | Automatic Collimator | Automatic Collimator | | | | Exposure switch | Exposure switch | Exposure switch | | | | Emergency stop switch | Emergency stop switch | Emergency stop switch | | | | Console PC set | Console PC set | Console PC set | | | Automatic | Panoramic exams | Panoramic exams | Panoramic exams | | | Collimator | Cephalometric exams | Cephalometric exams | Cephalometric exams | | | | | | | | | Display Type | TFT LCD type(Normally black) | TFT LCD type(Normally black) | TFT LCD type(Normally black) | | | | *1280x800 pixel | *1280x800 pixel | *1280x800 pixel | | | | | | | | | | Class I with type B applied parts | 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 | according to IEC 60601-1 | | | | | | | | | Focal size | 0.5 | 0.5 | 0:5 | | | | | | | | | Field of<br>View(CT) | 90x90mm | 90x90mm | 90x90mm | | | X-ray Voltage | 60~90kVp | 60~90kVp | 60~90kVp | | | X-ray Current | 4~17mA | 4~17mA | 4~17mA | | | Total<br>Filtration | 2.6 mm Al equivalent | 2.6 mm Al equivalent | 2.6 mm Al equivalent | | | Detector Pixel<br>size | Pano: 100 μm | Pano: 100 μm | Pano: 100 μm | | | | Ceph[Scan type]: 100 μm | Ceph[One shot type]: 150 μm | Ceph[One shot type]: 150 μm | | | | Ceph[One shot type, installed in α-M3DS]: 139 μm | | | | | | Ceph[One shot type, installed in α-M3DL]: 139 μm | | | | | Magnification | Pano : 1.31 | Pano : 1.31 | Pano : 1.31…