RCT700

K213226 · Ray Co., Ltd. · OAS · Nov 29, 2021 · Radiology

Device Facts

• Record ID: K213226
• Device Name: RCT700
• Applicant: Ray Co., Ltd.
• Product Code: OAS · Radiology
• Decision Date: Nov 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

RCT700 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway and ENT structure for diagnostic support for adult and pediatic 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

RCT700 is a CBCT, panoramic, and cephalometric X-ray system for dental/maxillofacial imaging. It uses a rotating C-arm with an integrated high-voltage X-ray generator and flat-panel detector to capture 2D panoramic/cephalometric images and 3D CBCT volumes. Operated by dentists or qualified professionals in clinical settings. The device reconstructs 3D images from multiple-angle scans. Output is viewed on workstations to support diagnosis of hard tissues (bone/teeth). Benefits include diagnostic support for orthodontic treatment, ENT, and maxillofacial conditions. Software manages image acquisition, storage, and inquiry.

Clinical Evidence

Bench testing performed per IEC 60601 and IEC 61223 standards. Clinical evidence included review of sample images by two licensed practitioners, confirming acceptable quality for intended use across all detector types and protocols. No clinical trials required for substantial equivalence; clinical images provided as supplemental evidence.

Technological Characteristics

CBCT/Panoramic/Cephalometric X-ray system. Materials: standard medical-grade components. Sensing: Flat-panel detectors (various models). Energy: High-frequency X-ray generator. Connectivity: Giga-Ethernet, DICOM 3.0 compatible. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-2. Software: RayScan (cleared under K182614).

Indications for Use

Indicated for radiographic examination of dento-maxillofacial, sinus, TMJ, airway, and ENT structures in adult and pediatric patients (recommended >5 years old). Includes optional model scan and cephalometric carpus imaging for orthodontic growth/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

• RCT700 (K182614)
• RCT800 (K192737)

Submission Summary (Full Text)

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November 29, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

RAY Co., Ltd % Ms. Youna Im RA Assistant Manager 332-7. Samsung 1-ro Hwaseong-si. 18380 REPUBLIC OF KOREA

Re: K213226

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 27, 2021 Received: September 29, 2021

Dear Ms. Im:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); 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 (QS) 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

# 510(k) Number (if known)

#### K213226

Device Name RCT700

#### Indications for Use (Describe)

RCT700 is CBCT and panoramic x-ray imaging system with cephalometric.

Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway and ENT structure for diagnostic support for adult and pediatic 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

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 [e-mail]

"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."

FORM FDA 3881 (6/20)

PSC Publishing Services [phone] EF

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# 5. 510(K) Summary

K213226

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# 510(k) Summary

#### K213226

#### 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 27, 2021
#### 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: 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 | Predicate Device-1 | Predicate Device-1 |
|--------------|--------------------|--------------------|
| Device Name | RCT700 | RCT800 |
| Manufacturer | RAY Co., Ltd | RAY Co., Ltd |

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| 510(K) Number | K182614 | K192737 |
|-------------------------|----------------------------------|----------------------------------|
| Classification name | Computed tomography x-ray system | Computed tomography x-ray system |
| Regulation number | 892.1750 | 892.1750 |
| Primary product<br>code | OAS | OAS |

#### 7. 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.

#### 8. Indication for use

RCT700 is CBCT and panoramic x-ray imaging system with cephalometric.

Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway and ENT structure 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

| Parameter | Proposed Device | Predicate Device-1 | Predicate Device-2 | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | |
| Device name | RCT700 | RCT700 | RCT800 | |
| 510(K) Number | (Traditional 510K) | K182614<br>(Special 510K) | K192737<br>(Traditional 510K) | |
| Common<br>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<br>for use | RCT700 is CBCT and panoramic x-ray<br>imaging system with cephalometric.<br>Which is intended to radiographic<br>examination of the dento-maxillofacial,<br>sinus, TMJ, Airway and ENT structure<br>for diagnostic support for adult and<br>pediatric patients. And a model scan is<br>included as an option. Cephalometric<br>image is also includes wrist to obtain<br>carpus images for growth and maturity<br>assessment for orthodontic treatment.<br>The device is to be operated and used<br>by dentists or other legally qualified<br>heath care professionals | RCT700, panoramic x-ray imaging<br>system with cephalostat, is an extraoral<br>source x-ray system, which is intended<br>for dental radiographic examination of<br>the teeth, jaw, and oral structures,<br>specifically for panoramic examinations<br>and implantology and for TMJ studies<br>and cephalometry, and it has the<br>capability, using the CBVT technique, to<br>generate dento-maxillo-facial 3D<br>images. The device uses cone shaped<br>x-ray beam projected on to a flat panel<br>detector, and the examined volume<br>image is reconstructed to be viewed in<br>3D viewing stations. 2D Images are<br>obtained using the standard narrow<br>beam technique. | RCT800 is CBCT and panoramic x-ray<br>imaging system with cephalometric.<br>Which is intended to radiographic<br>examination of the dento-maxillofacial,<br>sinus, TMJ, Airway for diagnostic<br>support for adult and pediatric patients.<br>And a model scan is included as an<br>option.<br>Cephalometric image is also includes<br>wrist to obtain carpus images for growth<br>and maturity assessment for orthodontic<br>treatment.<br>The device is to be operated and used<br>by dentists or other legally qualified<br>heath care professionals. | |
| Mode of<br>Operation | Same as predicate device #1 | Continuous operation with<br>intermittent, stated permissible<br>loading | Same as predicate device #1 | |
| 3D technology | Same as predicate device #1 | CBCT Cone beam<br>Computed Tomography | Same as predicate device #1 | |
| | | | | |
| Performance<br>Specification | | Same as predicate device #1 | 1) CBCT Computed tomography<br>- Patient<br>2) Panoramic<br>3) Cephalometric(optional)<br>- One shot type<br>- Scan type | 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<br>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,<br>Standard Type)<br>CT + PANO + One shot(One shot,<br>Large Type). | Same as predicate device #1 |
| Detector<br>Type | CT | Same as predicate device #1 | FXDD-0606CA | Same as predicate device #1 |
| | CT | Jupi0606X | SiX 650HD-E | FXDD-1012CH |
| | PANO | Same as predicate device #1 | FXDD-0606CA | Same as predicate device #1 |
| | PANO | Jupi0606X | SiX 650HD-E | FXDD-1012CH |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC | Same as predicate device #1 |
| | Ceph (One shot) | FXDD-1012CA | PaxScan 2530C | Same as predicate device #1 |
| | Ceph (One shot) | FXRD-1717VA | 1717SCC | Same as predicate device #1 |
| Exposure switch<br>Type | | Same as predicate device #1 | "Deadman" Button type | Same as predicate device #1 |
| Main<br>Components | | Same as predicate device #1 | Ceph Apparatus | Same as predicate device #1 |
| Main<br>Components | | Same as predicate device #1 | Vertical Carriage | Same as predicate device #1 |
| Main<br>Components | | 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<br>- CT<br>FXDD-0606CA<br>Jupi0606X<br><br>- PANO<br>FXDD-0606CA<br>Jupi0606X<br><br>- Ceph<br>XID-C24DC(Scan)<br>FXDD-1012CA(One shot, Standard<br>Size)<br>FXRD-1717VA(One shot, Large Size) | Detector<br>- CT<br>FXDD-0606CA<br>SIX 650HD-E<br><br>- PANO<br>FXDD-0606CA<br>SIX 650HD-E<br><br>- Ceph<br>XID-C24DC(Scan)<br>PaxScan 2530C(One shot, Standard<br>Size)<br>1717SCC(One shot, Large Size) | Detector<br>- CT<br>FXDD-0606CA<br>FXDD-1012CH<br><br>- PANO<br>FXDD-0606CA<br>FXDD-1012CHA<br><br>- Ceph<br>XID-C24DC(Scan)<br>PaxScan 2530C(One shot, Standard<br>Size)<br>1717SCC(One shot, Large Size) | |
| | Same as predicate device #1 | Chinrest | Same as predicate device #1 | |
| | Same as predicate device #1 | Head rest | Same as predicate device #1 | |
| | Same as predicate device #1 | Automatic Collimator | Same as predicate device #1 | |
| | Same as predicate device #1 | Exposure switch | Same as predicate device #1 | |
| | Same as predicate device #1 | Emergency stop switch | Same as predicate device #1 | |
| | Same as predicate device #1 | Console PC set | Same as predicate device #1…