RCT800

K181452 · Ray Co., Ltd. · OAS · Jul 27, 2018 · Radiology

Device Facts

• Record ID: K181452
• Device Name: RCT800
• Applicant: Ray Co., Ltd.
• Product Code: OAS · Radiology
• Decision Date: Jul 27, 2018
• 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 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 images of dento-maxillofacial structures. The device is operated by dentists or qualified healthcare professionals in a clinical setting. It transforms X-ray signals into digital images via indirect or direct conversion detectors. The system supports optional model scanning and carpus imaging for orthodontic assessment. Output is viewed on a monitor to assist in diagnosis and treatment planning. The device benefits patients by providing high-resolution diagnostic images for dental, sinus, and TMJ evaluation, as well as growth assessment, facilitating accurate clinical decision-making.

Clinical Evidence

No formal clinical trial was required for substantial equivalence. Clinical imaging samples were collected from two offices using the new detectors on random patients of varying age, gender, and size. Two licensed practitioners observed and verified that the images were acceptable for diagnostic purposes in the regions of interest, providing supplemental evidence to the bench testing.

Technological Characteristics

Computed tomography X-ray system; C-arm geometry; X-ray generator; flat-panel detectors (FXDD-0606CA, 1717SCC); Giga-Ethernet connectivity; DICOM 3.0 compatible. Standards: IEC 60601-1 (electrical/mechanical safety), IEC 60601-1-3 (radiation protection), IEC 60601-2-63 (particular requirements for dental X-ray), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for radiographic examination of dento-maxillofacial, sinus, TMJ, and airway structures in adult and pediatric patients (recommended >5 years old). Includes optional model scan and carpus imaging for orthodontic growth/maturity assessment. 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)
• Green Smart (Model: PHT-65LHS) (K170066)

Submission Summary (Full Text)

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July 27, 2018

Image /page/0/Picture/1 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ray Co., Ltd. % Changhwan Lee RA Manager 332-7, Samsung 1-ro Hwaseong-si, Gyeonggi-do 18380 REPUBLIC OF KOREA

Re: K181452

Trade/Device Name: RCT800 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 27, 2017 Received: June 6, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Sincerely,

for

for

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# 4. Indications for Use Statement

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# Indications for Use

510(k) Number (if known)

K181452

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.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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# 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: | May 27, 2018 |
|-------------------------------|--------------------------------------------------------------|
| 3. 510(k) Number | K181452 |
| 4. 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 : [phone] |
| | FAX : [phone] |
| Contact Person | e-mail : [e-mail] |

#### 5. 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 : II Product code : OAS Panel : Radiology

#### 6. Predicate device

| Parameter | Predicate Device-1 | Predicate Device-2 |
|--------------|--------------------|-----------------------------------|
| Device Name | RCT700 | Green Smart<br>(Model: PHT-65LHS) |
| Manufacturer | RAY Co., Ltd | Vatech Co., Ltd. |

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| 510(K) Number | K160525<br>Traditional 510k | K170066<br>Traditional 510k |
|----------------------|-------------------------------------|-------------------------------------|
| Classification name | Computed tomography x-ray<br>system | Computed tomography x-ray<br>system |
| Regulation number | 892.1750 | 892.1750 |
| Primary product code | OAS | 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.

## 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 functioning 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 Co.,Ltd Page 2

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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.

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# 11. Comparison with predicate device

The product is principally just the same as in the previous 510(k) #K160525.

The indications for use are expanded to include the model scan. But, the operating principle of the model scan is thought to be similar to previous 510(k) #K170066.

The expanded intended use of the RCT800 and the predicate device #K160525 and #K170066 is identical.

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. | Vatech Co., Ltd. | |
| Device name | RCT800 | RCT700 | Green16/Green18 | |
| 510(K) Number | K181452<br>(Traditional 510K) | K160525<br>(Traditional 510K) | K170066<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 Computed Tomography X-ray<br>System | |
| Indications<br>for use | 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. | 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. | PHT-65LHS is intended to produce<br>panoramic, cephalometric or 3D digital<br>x-ray images. It provides diagnostic<br>details of the dento-maxillofacial, ENT,<br>sinus and TMJ for adult and pediatric<br>patients. The system also utilizes carpal<br>images for orthodontic treatment. The<br>device is to be operated by healthcare<br>professionals. | |
| Mode of<br>Operation | Same as predicate device #1 | Continuous operation with<br>intermittent, stated permissible<br>loading | Continuous operation with<br>intermittent, stated permissible<br>loading | |
| 3D technology | Same as predicate device #1 | CBCT Cone beam<br>Computed Tomography | CBCT Cone beam<br>Computed Tomography | |
| Performance<br>Specification | 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 | 1) CBCT Computed tomography<br>2) Panoramic<br>3) Cephalometric(optional)<br>- One shot type<br>- Scan type | 1) CBCT Computed tomography<br>2) Panoramic<br>3) Cephalometric(optional)<br>- One shot 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). | Base<br>CT+PANO<br>Option(CEPH)<br>CT + PANO + CEPH | |
| Detector<br>Type | CT | FXDD-0606CA | SIX 650HD-E | Xmaru1314CF |
| | | | SIX 650HD-E | Xmaru1515CF |
| | PANO | FXDD-0606CA | C10500D | Xmaru1314CF |
| | | | SIX 650HD-E | Xmaru1515CF |
| | | | XID-C15DP | |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC | |
| | Ceph (One shot) | 1717SCC | PaxScan 4336X | |
| | | Same as predicate device #1 | PaxScan 2530C | Xmaru2602CF |
| Exposure switch<br>Type | Same as predicate device #1 | "Deadman" Button type | "Deadman" Button type | |
| Main<br>Components | Same as predicate device #1 | Ceph Apparatus | Ceph Apparatus | |
| | Same as predicate device #1 | Vertical Carriage | Vertical Carriage | |
| | Same as predicate device #1 | Rotator | Rotator | |
| | Same as predicate device #1 | X-RAY Generator | X-RAY Generator | |
| | Same as predicate device #1 | X-ray tube | X-ray tube | |
| | Same as predicate device #1 | High Frequency Generator | High Frequency Generator | |
| | Same as predicate device #1 | Column | Column | |
| | Same as predicate device #1 | Touch monitor (panel) | Touch monitor (panel) | |
| | Detector<br>- CT<br>FXDD-0606CA<br>- PANO<br>FXDD-0606CA<br>- Ceph<br>XID-C24DC(Scan)<br>1717SCC(One shot, Large Size)<br>PaxScan 2530C(One shot, Standard<br>Size) | Detector<br>- CT<br>SIX 650HD-E<br>- PANO<br>C10500D<br>SIX 650HD-E<br>XID-C15DP<br> | Detector<br>- CT<br>Xmaru1314CF<br>Xmaru1515CF<br>- PANO<br>Xmaru1314CF<br>Xmaru1515CF<br>- Ceph<br>Xmaru2602CF | |
| | Same as predicate device #1 | Chinrest | Chinrest | |
| | Same as predicate device #1 | Head rest | Head rest | |
| | 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<br>Collimator | | Same as predicate device #1 | CT exams<br>Panoramic exams<br>Cephalometric exams | Unknown |
| Display Type | | Same as predicate device #1 | TFT LCD type(Normally black)<br>*1280x800 pixel | Unknown |
| Class | | Same as predicate device #1 | Class I with type B applied parts<br>according to IEC 60601-1 | Class I with type B applied parts<br>according to IEC 60601-1 |
| Focal size | | Patient 0.5<br>Model scan 0.04 (Optional) | 0.5 | 0.5 |
| Field of<br>View(CT) | | Same as predicate device #1…