RCT800

K192737 · Ray Co., Ltd. · OAS · Oct 22, 2019 · Radiology

Device Facts

• Record ID: K192737
• Device Name: RCT800
• Applicant: Ray Co., Ltd.
• Product Code: OAS · Radiology
• Decision Date: Oct 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

RCT800 is a CBCT and panoramic X-ray imaging system with optional cephalometric and model scan capabilities. It utilizes a rotating C-arm equipped with an X-ray generator and detector to capture 2D panoramic/cephalometric images and 3D CBCT volumes of hard tissues (bone/teeth). A new 'Face Scan' mode captures 3D facial photos for soft tissue visualization. Operated by dentists or qualified professionals in clinical settings, the device transmits data via Giga-Ethernet to a console PC running RayScan software. The system aids clinicians in diagnostic support for dento-maxillofacial, sinus, TMJ, and airway conditions, and orthodontic treatment planning. The output consists of reconstructed digital images, which clinicians use to visualize anatomy, assess growth, and support clinical decision-making, potentially improving diagnostic accuracy and treatment outcomes.

Clinical Evidence

Bench testing performed per IEC 61223-3-4 and IEC 61223-3-5 confirmed imaging performance and patient dosage within tolerances. Clinical evidence consisted of sample images collected from two clinical sites using all available detectors. Images were reviewed by licensed practitioners and deemed of acceptable quality for the intended use. No formal clinical trial with primary endpoints was required; clinical images served as supplemental evidence.

Technological Characteristics

CBCT/Panoramic/Cephalometric X-ray system. Components: C-arm, high-frequency X-ray generator, digital detectors (FXDD-0606CA, FXDD-1012CHA, XID-C24DC, 1717SCC, PaxScan 2530C). Connectivity: Giga-Ethernet. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-2 (EMC). Max voltage: 100kVp. Filtration: Min 2.8 mm Al equivalent. Software: RayScan (K182805).

Indications for Use

Indicated for radiographic examination of dento-maxillofacial, sinus, TMJ, and airway for diagnostic support in adult and pediatric patients (recommended >5 years old). Includes model scan option and cephalometric imaging (including carpus/wrist) for orthodontic growth and maturity assessment.

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

• RCT800 (K182805)

Reference Devices

• CS 9600 (K118136)
• Planmeca ProMax 3D Max (K160506)

Submission Summary (Full Text)

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October 22, 2019

RAY CO., Ltd c/o Changhwan Lee RA Manager 332-7. Samsung 1-ro Hwaseong-si, Gyeonggi-do 18380 REPUBLIC OF KOREA

Re: K192737

Trade/Device Name: RCT800 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: September 25, 2019 Received: September 27, 2019

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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K192737

Device Name RCT800

Indications for Use (Describe)

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.

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Type of Use (Select one or both, as applicable)

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# 510(k) Summary

#### 1. 510(k) Summary

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

- 2. Date: September 25, 2019
#### 3. Administrative Information

| APPLICANT | RAY Co.,Ltd |
|----------------|----------------------------------------------------------------------------|
| ADDRESS | #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 18380, Korea |
| Manufacturer | RAY Co.,Ltd<br>332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 18380, Korea |
| | TEL : [phone]<br>FAX : [phone] |
| Contact Person | e-mail : [e-mail] |

#### 4. Device Information

#### Device Name

Trade/Proprietary Name: RCT800 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 | Predicate Device-1 |
|--------------|--------------------|
| Device Name | RCT800 |
| Manufacturer | RAY Co., Ltd |

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| 510(K) Number | K182805 |
|----------------------|----------------------------------|
| Classification name | Computed tomography x-ray system |
| Regulation number | 892.1750 |
| Primary product code | OAS |

### 7. Device Description

System purpose RCT800 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.

#### 8. Indication for use

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.

#### 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.

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## 10. Comparison with predicate device

The following table provides the summary of the technological characteristics of RCT800 compared to the predicate device.

| Parameter | Proposed Device | Predicate Device | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | |
| Device name | RCT800 | RCT800 | |
| 510(K) Number | (Traditional 510K) | K182805<br>(Special 510K) | |
| Common Name | Dental panoramic/tomography and cephalometric x-ray system | Dental panoramic/tomography and cephalometric x-ray system | |
| Indications for use | 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. | 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 | |
| 3D technology | Same as predicate device #1 | CBCT Cone beam<br>Computed Tomography | |
| Performance Specification | Same as predicate device #1 | 1) CBCT Computed tomography<br>- Patient<br>- Dental Model Scan(Optional)<br>2) Panoramic<br>3) Cephalometric(optional)<br>- One shot type<br>- Scan type | |
| Functional Option | Same as predicate device #1 | Base<br>CT+PANO<br>Option(CEPH)<br>CT + PANO + SCAN CEPH<br>CT + PANO + One shot(One shot, Standard Type)<br>CT + PANO + One shot(One shot, Large Type). | |
| Detector Type | CT | Same as predicate device #1 | FXDD-0606CA |
| | CT | Same as predicate device #1 | FXDD-1012CHA |
| | PANO | Same as predicate device #1 | FXDD-0606CA |
| | PANO | Same as predicate device #1 | FXDD-1012CHA |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC |
| Exposure switch<br>Type | Ceph (One shot) | Same as predicate device #1 | 1717SCC |
| | | Same as predicate device #1 | PaxScan 2530C |
| | | Same as predicate device #1 | "Deadman" Button type |
| Main<br>Components | | Same as predicate device #1 | Ceph Apparatus |
| | | Same as predicate device #1 | Vertical Carriage |
| | | Same as predicate device #1 | Rotator |
| | | Same as predicate device #1 | X-RAY Generator |
| | | Same as predicate device #1 | X-ray tube |
| | | Same as predicate device #1 | High Frequency Generator |
| | | Same as predicate device #1 | Column |
| | | Same as predicate device #1 | Touch monitor (panel) |
| | | Same as predicate device #1 | Detector<br>- CT<br>FXDD-0606CA<br>FXDD-1012CHA<br>- PANO<br>FXDD-0606CA<br>FXDD-1012CHA<br>- Ceph<br>XID-C24DC(Scan)<br>1717SCC(One shot, Large Size)<br>PaxScan 2530C(One shot, Standard<br>Size) |
| | | Same as predicate device #1 | Chinrest |
| | | Same as predicate device #1 | Head rest |
| | | Same as predicate device #1 | Automatic Collimator |
| | Same as predicate device #1 | Exposure switch | |
| | Same as predicate device #1 | Emergency stop switch | |
| | Same as predicate device #1 | Console PC set | |
| Automatic<br>Collimator | | Same as predicate device #1 | CT exams<br>Panoramic exams<br>Cephalometric exams |
| Display Type | | Same as predicate device #1 | TFT LCD type(Normally black)<br>*1280x800 pixel |
| Class | | Same as predicate device #1 | Class I with type B applied parts<br>according to IEC 60601-1 |
| Focal size | | Same as predicate device #1 | Patient 0.5<br>Model scan 0.04 (Optional) |
| Field of<br>View(CT) | | Same as predicate device #1 | FXDD-0606CA : Max.160x100 mm<br>FXDD-1012CHA : Max. 200x200 mm |
| | | | |
| X-ray Voltage(Patient) | | 60~100kVp | 60~90kVp |
| X-ray Current(Patient) | | Same as predicate device #1 | 4~17mA |
| X-ray Voltage(Model Scan, Optional) | | Same as predicate device #1 | 50~80kVp |
| X-ray Current(Model Scan, Optional) | | Same as predicate device #1 | 0.4~0.7mA |
| Total Filtration | | Same as predicate device #1 | Min. 2.8 mm Al equivalent |
| Detector<br>Pixel size | CT | Same as predicate device #1 | FXDD-0606CA: 119µm |
| | CT | Same as predicate device #1 | FXDD-1012CHA: 124µm |
| | PANO | Same as predicate device #1 | FXDD-0606CA: 119µm |
| | PANO | Same as predicate device #1 | FXDD-1012CHA: 124µm |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 100µm |
| | Ceph(One shot) | Same as predicate device #1 | 1717SCC: 127µm |
| | Ceph(One shot) | Same as predicate device #1 | PaxScan 2530C: 139µm |
| Magnification | CT | Same as predicate device #1 | FXDD-0606CA: 1.44(Patient)<br>1.91(Model Scan) |
| | CT | Same as predicate device #1 | FXDD-1012CHA: 1.44(Patient)<br>1.91(Model Scan) |
| | PANO | Same as predicate device #1 | FXDD-0606CA: 1.3 |
| | PANO | Same as predicate device #1 | FXDD-1012CHA: 1.3 |
| | Ceph (Scan) | Same as predicate device #1…