(25 days)
Not Found
No
The summary describes a standard CBCT/panoramic/cephalometric x-ray system and does not mention any AI or ML capabilities in its intended use, device description, or performance studies. There is no mention of image processing techniques that typically involve AI/ML, nor are there descriptions of training or test sets for such algorithms.
No.
This device is an imaging system (CBCT, panoramic x-ray) used for dental radiographic examination and diagnosis, not for therapeutic intervention.
Yes
The intended use states the device is for "dental radiographic examination" and for the "clinical diagnosis and structures are acceptable in the region of interests," which clearly indicates a diagnostic purpose.
No
The device description clearly outlines hardware components like an x-ray tube, detector, and c-arm, indicating it is a physical imaging system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is an X-ray imaging system that directly examines the patient's body (teeth, jaw, oral structures, etc.) using radiation.
- The intended use and device description clearly state it's for radiographic examination and generating images of anatomical structures. This is a diagnostic imaging device, not a device for testing biological samples.
- There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
The device described is a medical imaging device used for in-vivo (within the living body) diagnosis.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
OAS
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.
Mentions image processing
The examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam technique.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cone beam x-ray
Anatomical Site
teeth, jaw, and oral structures, dento-maxillofacial, sinus, TMJ, Airway, carpus (for cephalometric image of wrist)
Indicated Patient Age Range
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.
Intended User / Care Setting
"CAUTION: Federal law restricts this device to sale by or on the order of a dentist."
The device is to be operated and used by dentists or other legally qualified heath care professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench"
Bench testing is used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4 and IEC 61223-3-5.
Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices".
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical considerations were conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 20".
Clinical images were provided these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
For clinical testing, two licensed practitioners/clinicians observed and verified that dental X ray system from RCT700.
The clinical imaging samples are collected from the new detector on propose device at the 2 offices where the predicate device is installed on clinical consideration report for the clinical test images. These images were gathered from the new detector installed with RCT700 on any protocols with random patient age, gender, and size. As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests.
All test results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
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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
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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/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
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4. Indications for Use Statement
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Indications for Use
510(k) Number (if known)
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) |
|---|
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Department of Health and Human Services |
|---|
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See PRA Statement below.
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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.
-
- 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 |
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| 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
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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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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 |
- Panoramic
- Cephalometric(optional)
- One shot type
- Scan type | 1) CBCT Computed tomography
- Patient
- Dental Model Scan(Optional)
- Panoramic
- 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 | |
| X-ray Voltage(Patient) | Same as predicate device #1 | 6090kVp | Same as predicate device #1 | |17mA | Same as predicate device #1 | |
| X-ray Current(Patient) | Same as predicate device #1 | 4
| Total Filtration | Same as predicate device #2 | Min. 2.75 mm Al equivalent | Min. 2.8 mm Al equivalent | |
| CT | Same as predicate device #1 | SIX 650HD-E: 150μm | | |
| | Same as predicate device #2 | | FXDD-0606CA: 119μm | |
| Detector
Pixel size
PANO | Same as predicate device #1 | C10500D: 100μm | N/A | |
| | Same as predicate device #1 | SIX 650HD-E: 150μm | N/A | |
| | Same as predicate device #1 | XID-C15DP: 100μm | N/A | |
| | Same as predicate device #2 | N/A | FXDD-0606CA: 119μm | |
| | | | | |
| | | | | |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 100µm | Same as predicate device #1 |
| | Ceph(One shot) | Same as predicate device #2 | N/A | N/A |
| | | Same as predicate device #1 | PaxScan 4336X: 139µm | N/A |
| | | Same as predicate device #1 | PaxScan 2530C: 139µm | Same as predicate device #1 |
| Magnification | CT | SIX 650HD-E : 1.45
FXDD-0606CA: 1.44 | SIX 650HD-E: 1.39 | FXDD-0606CA: 1.44(Patient) |
| | PANO | C10500D: 1.3 | C10500D: 1.31 | N/A |
| | | SIX 650HD-E: 1.3 | SIX 650HD-E: 1.31 | N/A |
| | | XID-C15DP: 1.3 | XID-C15DP: 1.31 | N/A |
| | | Same as predicate device #2 | N/A | FXDD-0606CA: 1.3 |
| | | Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 1.11 |
| | | Ceph(One shot) | Same as predicate device #1 | PaxScan 4336X: 1.13 |
| | | | Same as predicate device #2 | N/A |
| | | Same as predicate device #1 | PaxScan 2530C: 1.12 | Same as predicate device #1 |
| | Scan time | Same as predicate device #1 | CT : below 14sec(Patient) | Same as predicate device #1 |
| | | Same as predicate device #1 | Pano : below 14sec | Same as predicate device #1 |
| | | Same as predicate device #2 | Ceph[Scan type] : below 18sec | Ceph[Scan type] : below 19sec |
| | | Same as predicate device #1 | Ceph[One shot type]:
below 2sec | Same as predicate device #1 |
| | Format compatible | Same as predicate device #1 | DICOM 3.0 Format compatible | Same as predicate device #1 |
| | Image Viewing Software | Same as predicate device #1 | RayScan
(Cleared under K160525) | RayScan
(Cleared under K181452) |
| | Image acquisition | Same as predicate device #1 | Giga-Ethernet Network | Same as predicate device #1 |
| | Total Height | Same as predicate device #1 | Max 2,296mm | Same as predicate device #1 |
| | 1) Computed Tomography(CT) +
Panoramic(PANO)=185kg(407.9lb) ± 10% | 1) Computed Tomography(CT) +
Panoramic(PANO)=150kg(331lb) ± 10% | 1) Computed Tomography(CT) +
Panoramic(PANO)=189kg(416.6lb) ± 10% | |
| | 2) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(Scan type)= 212.5kg (468.5lb) ± 10% | 2) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(Scan type)= 166kg (366lb) ± 10% | 2) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(Scan type)= 219kg (482.8lb) ± 10% | |
| Weight | 3) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Standard size)= 211kg (465.2lb) ± 10% | 3) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Standard size)= 166kg (366lb) ± 10% | 3) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Standard size)= 217kg (478.4lb) ± 10% | |
| | 4) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Large size)
211kg (465.2lb) ± 10% | 4) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Large size)
166kg (366lb) ± 10% | 4) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Large size)
212kg (467.3lb) ± 10% | |
| Type of
installation | Same as predicate device #1 | Wall or floor mount | Wall or floor mount | |
| Patient position | Same as predicate device #1 | Standing / Wheelchair | Standing / Wheelchair | |
| Applicable
Standards | Same as predicate device #2 | IEC 60601-1
IEC 60601-1-3
IEC 60601-2-28
IEC 60601-2-63
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-3
IEC 60601-2-63
IEC 60601-1-2 | |
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11. Safety and Effectiveness Information
RCT700 system described in this 510(k) is similar to the predicate device in terms of indications for use, materials, safety characteristics, and X-ray source.
The following information further substantial equivalence between the subject device and predicate device.
The fundamental technological characteristics of the subject and predicate device are similar.
The imaging modes are similar; PANO, CEPH (Optional), CBCT, Scan All viewing software programs have been same with previous 510k submissions; RAYSCAN(K160525).
RCT700 used FPJ filter in CBCT on the RAYSCAN software. And CBCT principle is same previous device RCT700.
The sponsor tested the subject device in a laboratory and provided a non-clinical performance report. The same test protocol was used to test the performance of the subject and the predicate device for comparison. The sponsor certifies that adequate design and development controls (according to 21 CFR 820.30) were in place for manufacturing the subject device.
The differences are as follows.
- The subject device is equipped with new detectors, FXDD-0606CA, 1717SCC.
Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1: 2005/AMD1:2012(3.1 Edition), IEC 60601-1-3: 2008/AMD1:2013(Second Edition), IEC 60601-1-6:2010(Third Edition) and IEC 60601-2-63: 2012(first Edition) were performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2014(Edition 4.0).
The software of RCT700 saves the patient and image data and offers an inquiry function, in addition, supports the image generate function intended to obtain images using the RCT700 equipment and various sensors for diagnosis. And that has been validated according to FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" to assure substantial equivalence.
The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.
As a result, we identified the level of concern associated with new device and provided documentation consistent with that level. Based on our risk analysis of software, the difference does not affect its safety and effectiveness.
Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench"
Bench testing is used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4 and IEC 61223-3-5.
All test results were satisfactory.
Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices".
RCT700 is equipped with FXDD-0606CA. FXDD-0606CA is a new SSXI detector, which is used to capture an image in panoramic, CBCT mode.
Based on Non-Clinical Test results of FXDD-0606CA for the subject device, is similar to that of the SiX 650HD-E for the Predicate device. And equipped with 1717SCC is a new SSXI detector, which is used to capture an image in Cephalometric. Based on Non-Clinical Test results of 1717SCC for the subject device, is similar to that of the PaxScan 4336X for the Predicate device.
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All test results were satisfactory.
Clinical considerations were conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 20".
Clinical images were provided these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
For clinical testing, two licensed practitioners/clinicians observed and verified that dental X ray system from RCT700.
The clinical imaging samples are collected from the new detector on propose device at the 2 offices where the predicate device is installed on clinical consideration report for the clinical test images. These images were gathered from the new detector installed with RCT700 on any protocols with random patient age, gender, and size. As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests.
12. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. RAY Co., Ltd. concludes that the newly RCT700 is safe and effective and substantially equivalent to predicate device as described herein.