R2 Studio Q/RCT820

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December 6, 2022 MegaGen Implant CO., Ltd. % Yong Jae Kim Research Engineer 45, Secheon-ro, 7-gil Daegu, Dasa-eup, Dalesong-gun 42921 KOREA Re: K222219 Trade/Device Name: R2 Studio Q/RCT820 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: July 18, 2022 Received: November 10, 2022 Dear Yong Jae Kim: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 2022.12.06 07:13:02 -05'00' Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222219 Device Name R2 STUDIO Q/RCT820 ## Indications for Use (Describe) R2 STUDIO Q/RCT820 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified health care professionals. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # 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}------------------------------------------------ ## 1. 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. 2. Date: July 18, 2022 ## 3. Administrative Information | APPLICANT | MegaGen Implant Co., Ltd. | |--------------|-----------------------------------------------------------------------------------------------------| | ADDRESS | 45, Secheon-ro, 7gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea | | Manufacturer | MegaGen Implant Co., Ltd.<br>45, Secheon-ro, 7gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea | | | TEL: +82-53-247-2261<br>FAX: +82-53-247-2254 | Contact Person e-mail: ra3@imegagen.com # 4. Device Information #### Device Name Trade/Proprietary Name: R2 STUDIO Q/RCT820 Common Name: Dental panoramic/tomography and cephalometric x-ray system # Classification Classification Name: Computed tomography x-ray system Regulation Number: 21 CFR 892.1750 Class: Il Product code: OAS Panel: Radiology #### 5. Predicate device & Reference Device | Parameter | Predicate Device | Reference Device | |----------------------|----------------------------------|----------------------------------| | Device Name | RCT800 | RCT700 | | Manufacturer | RAY Co., Ltd | RAY Co., Ltd | | 510(k) Number | K192737 | K213226 | | Classification name | Computed tomography x-ray system | Computed tomography x-ray system | | Regulation number | 892.1750 | 892.1750 | | Primary product code | OAS | OAS | {4}------------------------------------------------ ## 7. Device Description System purpose R2 STUDIO Q/RCT820 is 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that are scanned from different angle. Panoramic image scanning function for attaining image of whole teeth, cephalometric scanning option for attaining cephalic image are included. and Model Scan option for attaining dental model CBCT image are included. ## 8. Indication for use R2 STUDIO Q/RCT820 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified heath care professionals. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height measurements approximately correspond to that of an average 5 vear old. # 9. 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. # 10. Operating principle 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 functions 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 in 2D or/and 3D as preferred to diagnose in a monitor. CBCT provides in 3D images as reconstructed and Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 3 functions could be in 1 system, Panorama with Cephalometric, 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 method depending on the interior structure materials. {5}------------------------------------------------ # 11. Comparison with predicate devices The following table provides the summary of the technological characteristics of R2 STUDIO Q/RCT820 compared to the ence. | Parameter | Proposed Device | Predicate Device | Reference Device | | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------| | Manufacturer | MegaGen Implant Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | | | Device name | R2 STUDIO Q/RCT820 | RCT800 | RCT700 | | | 510(k) Number | (Traditional 510(k)) | K192737 | K213226 | | | | | (Traditional 510(k)) | (Traditional 510(k)) | | | Common Name | Dental panoramic/tomography and<br>cephalometric x-ray system | Dental panoramic/tomography and<br>cephalometric x-ray system | Dental panoramic/tomography and<br>cephalometric x-ray system | | | Indications for use | R2 STUDIO Q/RCT820 is CBCT and panoramic<br>x-ray imaging system with cephalometric.<br>Which is intended to radiographic<br>examination of the dento-maxillofacial, sinus,<br>TMJ, Airway for diagnostic support for adult<br>and pediatric patients. And a model scan is<br>included as an option.<br>Cephalometric image is also includes wrist to<br>obtain carpus images for growth and maturity<br>assessment for orthodontic treatment.<br>The device is to be operated and used by<br>dentists or other legally qualified heath care<br>professionals.<br>This device is not intended for use on patients<br>less than approximately 21 kg (46 lb) in weight<br>and 113 cm (44.5 in) in height; these height<br>and weight measurements approximately<br>correspond to that of an average 5 year old. | RCT800 is CBCT and panoramic x-ray imaging<br>system with cephalometric.<br>Which is intended to radiographic<br>examination of the dento-maxillofacial, sinus,<br>TMJ, Airway for diagnostic support for adult<br>and pediatric patients. And a model scan is<br>included as an option.<br>Cephalometric image is also includes wrist to<br>obtain carpus images for growth and maturity<br>assessment for orthodontic treatment.<br>The device is to be operated and used by<br>dentists or other legally qualified heath care<br>professionals. | RCT700 is CBCT and panoramic x-ray imaging<br>system with cephalometric. Which is intended<br>to radiographic examination of the dento-<br>maxillofacial, sinus, TMJ, Airway and ENT<br>structure for diagnostic support for adult and<br>pediatric patients. And a model scan is<br>included as an option. Cephalometric image is<br>also includes wrist to obtain carpus images for<br>growth and maturity assessment for<br>orthodontic treatment. The device is to be<br>operated and used by dentists or other legally<br>qualified heath care professionals. | | | Mode of Operation | Continuous operation with intermittent,<br>stated permissible loading | Continuous operation with intermittent,<br>stated permissible loading | Continuous operation with intermittent,<br>stated permissible loading | | | 3D technology | CBCT Cone beam | CBCT Cone beam | CBCT Cone beam | | | | Computed Tomography | Computed Tomography | Computed Tomography | | | Performance Specification | 1) CBCT Computed tomography | 1) CBCT Computed tomography | 1) CBCT Computed tomography | | | | - Patient | - Patient | - Patient | | | | - Dental Model Scan(Optional) | - Dental Model Scan(Optional) | - Dental Model Scan(Optional) | | | | 2) Panoramic | 2) Panoramic | 2) Panoramic | | | | 3) Cephalometric(optional) | 3) Cephalometric(optional) | 3) Cephalometric(optional) | | | | - Scan type | - One shot type | - One shot type | | | | | | - Scan type | | | | | | - Scan type | | | | | Base | Base | Base | | | | CT + PANO | CT + PANO | CT + PANO | | | | | | | | | | Option(CEPH) | Option(CEPH) | Option(CEPH) | | | | CT + PANO + SCAN CEPH | CT + PANO + SCAN CEPH | CT + PANO + SCAN CEPH | | Functional Option | | | | | | | | CT + PANO + One shot(One shot, Standard | CT + PANO + One shot(One shot, Standard | | | | | Type) | Type) | | | | | | | | | | | | CT + PANO + One shot(One shot, Large Type) | CT + PANO + One shot(One shot, Large Type) | | | CT | FXDD-1724R | FXDD-0606CA | FXDD-0606CA | | | | | FXDD-1012CHA | Jupi0606X | | | PANO | FXDD-1724R | FXDD-0606CA | FXDD-0606CA | | Detector Type | | | FXDD-1012CHA | Jupi0606X | | | Ceph (Scan) | XID-C24DC | XID-C24DC | XID-C24DC | | | Ceph (One shot)…