Who is the manufacturer of RCT700?

Ray Co., Ltd. filed the 510(k) submission for RCT700 (K182614).

What is the FDA product code for RCT700?

OAS. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for RCT700?

510(k) clearance (submission type: Special).

What are the predicate devices for RCT700?

RCT700 (K160525); RCT800 (K181452).

Who can help prepare an FDA 510(k) submission like RCT700?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RCT700

K182614 · Ray Co., Ltd. · OAS · Oct 16, 2018 · Radiology

Device Facts

Record ID	K182614
Device Name	RCT700
Applicant	Ray Co., Ltd.
Product Code	OAS · Radiology
Decision Date	Oct 16, 2018
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Intended Use

CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral 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 dental maxillofacial 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.

Device Story

RCT700 is a dental CBCT, panoramic, and cephalometric X-ray system. It uses a rotating C-arm with an X-ray generator and flat panel detector to capture 2D and 3D maxillofacial images. The device is operated by dentists or qualified healthcare professionals in clinical settings. It transforms X-ray signals into digital images via direct or indirect detection methods. The system includes a PC for image reconstruction and viewing. Output images are used by clinicians for diagnosis and treatment planning, such as implantology and orthodontics. Benefits include improved visualization of dental and maxillofacial structures for accurate clinical decision-making.

Clinical Evidence

Clinical evaluation involved two licensed practitioners observing and verifying system performance. Clinical images were collected from the new detectors (FXDD-0606CA, 1717SCC) at two clinical sites across various patient demographics. Practitioners confirmed that clinical diagnosis and visualization of structures were acceptable in the regions of interest. This data supplemented extensive non-clinical bench testing.

Technological Characteristics

Extra-oral X-ray system; C-arm geometry; high-frequency generator; flat panel detectors (FXDD-0606CA, 1717SCC); 60-90kVp; 4-17mA; 0.5mm focal spot; DICOM 3.0 compatible; Giga-Ethernet connectivity; wall/floor mount; Class I with Type B applied parts; IEC 60601-1, 60601-1-3, 60601-2-63, 60601-1-2 compliance.

Indications for Use

Indicated for dental radiographic examination of teeth, jaw, and oral structures (panoramic, implantology, TMJ, cephalometry, maxillofacial 3D imaging) in patients over 5 years old. No restrictions on gender, weight, or health condition.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

RCT700 (K160525)
RCT800 (K181452)

Related Devices

K213226 — RCT700 · Ray Co., Ltd. · Nov 29, 2021
K251798 — RCT700 · Ray Co., Ltd. · Nov 25, 2025
K181452 — RCT800 · Ray Co., Ltd. · Jul 27, 2018
K182805 — RCT800 · Ray Co., Ltd. · Dec 14, 2018
K230753 — RCT800 · Ray Co., Ltd. · Apr 11, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 16, 2018 RAY Co.,Ltd Changhwan Lee RA Manager 332-7, Samsung 1-ro, Hwaseong-si Gyeonggi-do, 18380 Korea Re: K182614 Trade/Device Name: RCT700 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: September 19, 2018 Received: September 21, 2018 Dear Changhwan Lee: 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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 4. Indications for Use Statement {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K182614 Device Name RCT700 Indications for Use (Describe) CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral 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 dental maxillofacial 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. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> ❌ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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 | | <a href="mailto:PRAStaff@fda.hhs.gov">PRAStaff@fda.hhs.gov</a> | *"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."* PSC Publishing Services (301) 443-6740 EF Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {4}------------------------------------------------ # 5. 510(K) Summary {5}------------------------------------------------ ### 510(k) Summary #### 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: August 29, 2018 #### 3. Administrative Information | APPLICANT | RAY Co.,Ltd | |----------------|----------------------------------------------------------------------------| | ADDRESS | #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 18380, Korea | | Manufacturer | RAY Co.,Ltd 332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 18380, Korea | | | TEL : +82-31-605-1000 FAX : +82-2-6280-5534 | | Contact Person | e-mail: ch0406.lee@raymedical.co.kr | #### 4. Device Information #### Device Name Trade/Proprietary Name: RCT700 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 | Parameter | Predicated Device-1 | Predicated Device-2 | |---------------|-----------------------------|-----------------------------| | Device Name | RCT700 | RCT800 | | Manufacturer | RAY Co., Ltd | RAY Co., Ltd | | 510(K) Number | K160525 Traditional 510k | K181452 Traditional 510k | {6}------------------------------------------------ | Classification name | Computed tomography x-ray system | Computed tomography x-ray system | |----------------------|-------------------------------------|-------------------------------------| | Regulation number | 892.1750 | 892.1750 | | Primary product code | OAS | OAS | #### 6. Device Description System purpose RCT700 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, and Model Scan option for attaining dental model CBCT image are included. #### 7. Indication for use CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral 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 dental maxillofacial 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 law restricts this device to sale by or on the order of a dentist." #### 8. 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. #### 9. 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 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 Xray generator to get the image of interests. The purpose of this mechanism is to provide the images in Ray Co.,Ltd Page 5-3 {7}------------------------------------------------ 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. {8}------------------------------------------------ ## 10. Comparison with predicate device The product is principally just the same as in the previous 510(k) #K160525. We changed a some scan protocol from the Predicate Device(K160525). And added a CT/Pano and ceph detector to the predicate Device #K160525. But, these detectors is used predicate Device #K181452. The compared technical features for imaging parameters, resolution, and other basic characteristics are matching very closely, and the differences are so small that they do not have any effect on performance in practice. Both devices conformance standards. | Parameter | Proposed Device | Predicate Device | Predicated Device | | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | RAY CO., Ltd. | | | Device name | RCT700 | RCT700 | RCT800 | | | 510(K) Number | (Special 510K) | K160525 (Traditional 510K) | K181452 (Traditional 510K) | | | Common Name | Dental panoramic/tomography and cephalometric x-ray system | Dental panoramic/tomography and cephalometric x-ray system | Dental panoramic/tomography and cephalometric x-ray system | | | Indications for use | Same as predicate device #1 | RCT700, 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 Images are obtained using the standard narrow beam technique. | RCT800 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. | | | Mode of Operation | | | | | | | Same as predicate device #1 | Continuous operation with intermittent, stated permissible loading | Same as predicate device #1 | | | 3D technology | Same as predicate device #1 | CBCT Cone beam Computed Tomography | Same as predicate device #1 | | | Performance Specification | Same as predicate device #1 | 1) CBCT Computed tomography 2) Panoramic 3) Cephalometric(optional) - One shot type - Scan type | 1) CBCT Computed tomography - Patient - Dental Model Scan(Optional) 2) Panoramic 3) Cephalometric(optional) - One shot type - Scan type | | | Functional Option | Same as predicate device #1 | Base CT+PANO Option(CEPH) CT + PANO + SCAN CEPH CT + PANO + One shot(One shot, Standard Type) CT + PANO + One shot(One shot, Large Type). | Same as predicate device #1 | | | Detector Type | CT | Same as predicate device #1 | SiX 650HD-E | N/A | | | CT | Same as predicate device #2 | N/A | FXDD-0606CA | | | PANO | Same as predicate device #1 | C10500D | N/A | | | PANO | Same as predicate device #1 | SiX 650HD-E | N/A | | | PANO | Same as predicate device #1 | XID-C15DP | N/A | | | Ceph (Scan) | Same as predicate device #2 | N/A | FXDD-0606CA | | | Ceph (Scan) | Same as predicate device #1 | XID-C24DC | Same as predicate device #1 | | | Ceph (One shot) | Same as predicate device #1 | PaxScan 4336X | N/A | | | | Same as predicate device #2 | N/A | 1717SCC | | | | Same as predicate device #1 | PaxScan 2530C | Same as predicate device #1 | | Exposure switch Type | | Same as predicate device #1 | "Deadman" Button type | Same as predicate device #1 | | Main Components | | Same as predicate device #1 | Ceph Apparatus | Same as predicate device #1 | | | | Same as predicate device #1 | Vertical Carriage | Same as predicate device #1 | | | | Same as predicate device #1 | Rotator | Same as predicate device #1 | | | | Same as predicate device #1 | X-RAY Generator | Same as predicate device #1 | | | | Same as predicate device #1 | X-ray tube | Same as predicate device #1 | | | | Same as predicate device #1 | High Frequency Generator | Same as predicate device #1 | | | | Same as predicate device #1 | Column | Same as predicate device #1 | | | | Same as predicate device #1 | Touch monitor (panel) | Same as predicate device #1 | | | | Detector - CT SIX 650HD-E FXDD-0606CA - PANO C10500D SIX 650HD-E XID-C15DP FXDD-0606CA - Ceph XID-C24DC(Scan) PaxScan 4336X(One shot, Large Size) 1717SCC(One shot, Large Size) PaxScan 2530C(One shot, Standard Size) | Detector - CT SIX 650HD-E - PANO C10500D SIX 650HD-E XID-C15DP - Ceph XID-C24DC(Scan) PaxScan 4336X(One shot, Large Size) PaxScan 2530C(One shot, Standard Size) | Detector - CT FXDD-0606CA - PANO FXDD-0606CA - Ceph XID-C24DC(Scan) 1717SCC(One shot, Large Size) PaxScan 2530C(One shot, Standard Size) | | | | Same as predicate device #1 | Chinrest | Chinrest | | | | | | | | | Same as predicate device #1 | Head rest | Head rest | | | Automatic Collimator | Same as predicate device #1 | Automatic Collimator | Unknown | | | | Same as predicate device #1 | Exposure switch | Exposure switch | | | | Same as predicate device #1 | Emergency stop switch | Emergency stop switch | | | | Same as predicate device #1 | Console PC set | Console PC set | | | Automatic Collimator | Same as predicate device #1 | CT exams Panoramic exams Cephalometric exams | Same as predicate device #1 | | | Display Type | Same as predicate device #1 | TFT LCD type(Normally black) *1280x800 pixel | Same as predicate device #1 | | | Class | Same as predicate device #1 | Class I with type B applied parts according to IEC 60601-1 | Same as predicate device #1 | | | Focal size | Same as predicate device #1 | 0.5 | Patient 0.5 Model scan 0.04 (Optional) | | | Field of View(CT) | Same as predicate device #1 | Max.160x100 mm | Same as predicate device #1…