(134 days)
No
The summary does not mention AI, ML, or related concepts like deep learning, neural networks, training sets, or performance metrics typically associated with AI/ML algorithms. The focus is on the imaging modalities and basic image processing.
No.
This device is an imaging system intended for diagnostic support, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "diagnostic support".
No
The device description explicitly states it is a "CBCT and panoramic x-ray imaging system with cephalometric" and describes hardware components like a "c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector". This indicates it is a hardware device that likely includes software for operation and image processing, but it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The R2 STUDIO Q/RCT820 is an imaging system. It uses X-rays (CBCT, panoramic, cephalometric) to create images of the internal structures of the body (dento-maxillofacial, sinus, TMJ, Airway, wrist).
- Intended Use: The intended use is for radiographic examination and diagnostic support based on these images. It does not involve analyzing biological samples.
The device is a medical imaging device, specifically a dental and maxillofacial imaging system.
N/A
Intended Use / Indications for Use
R2 STUDIO Q/RCT820 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 health care professionals. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
Product codes
OAS
Device Description
R2 STUDIO Q/RCT820 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 are included. and Model Scan option for attaining dental model CBCT image are included.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dento-maxillofacial, sinus, TMJ, Airway, wrist (carpus), whole teeth, head
Indicated Patient Age Range
adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
Intended User / Care Setting
dentists or other legally qualified health 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Test – Bench Test: Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - 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 61223-3-7. 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". RCT820 is equipped with FXDD-1724R. FXDD-1724R is a new SSXI detector, which is used to capture an image in panoramic, CBCT. Sample images with a clinical evaluation report is provided to support the intended use of the device. Based on Non-Clinical and Clinical Test results of FXDD-1724R for the subject device, is similar to that of the Jupi0606X for the reference device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2022
MegaGen Implant CO., Ltd. % Yong Jae Kim Research Engineer 45, Secheon-ro, 7-gil Daegu, Dasa-eup, Dalesong-gun 42921 KOREA
Re: K222219
Trade/Device Name: R2 Studio Q/RCT820 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: July 18, 2022 Received: November 10, 2022
Dear Yong Jae Kim:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
2022.12.06
07:13:02
-05'00'
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of 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)
Device Name R2 STUDIO Q/RCT820
Indications for Use (Describe)
R2 STUDIO Q/RCT820 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 health care professionals.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
| 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)
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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: July 18, 2022
3. Administrative Information
| APPLICANT | MegaGen Implant Co., Ltd. |
|---|---|
| ADDRESS | 45, Secheon-ro, 7gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea |
| Manufacturer | MegaGen Implant Co., Ltd. |
| 45, Secheon-ro, 7gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea | |
| TEL: +82-53-247-2261 | |
| FAX: +82-53-247-2254 |
Contact Person e-mail: ra3@imegagen.com
4. Device Information
Device Name
Trade/Proprietary Name: R2 STUDIO Q/RCT820 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 & Reference Device
| Parameter | Predicate Device | Reference Device |
|---|---|---|
| Device Name | RCT800 | RCT700 |
| Manufacturer | RAY Co., Ltd | RAY Co., Ltd |
| 510(k) Number | K192737 | K213226 |
| Classification name | Computed tomography x-ray system | Computed tomography x-ray system |
| Regulation number | 892.1750 | 892.1750 |
| Primary product code | OAS | OAS |
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7. Device Description
System purpose R2 STUDIO Q/RCT820 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 are included. and Model Scan option for attaining dental model CBCT image are included.
8. Indication for use
R2 STUDIO Q/RCT820 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.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height measurements approximately correspond to that of an average 5 vear old.
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 functions 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 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 devices
The following table provides the summary of the technological characteristics of R2 STUDIO Q/RCT820 compared to the ence.
| Parameter | Proposed Device | Predicate Device | Reference Device | |
|---|---|---|---|---|
| Manufacturer | MegaGen Implant Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | |
| Device name | R2 STUDIO Q/RCT820 | RCT800 | RCT700 | |
| 510(k) Number | (Traditional 510(k)) | K192737 | K213226 | |
| (Traditional 510(k)) | (Traditional 510(k)) | |||
| 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 | R2 STUDIO Q/RCT820 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. | ||||
| This device is not intended for use on patients | ||||
| less than approximately 21 kg (46 lb) in weight | ||||
| and 113 cm (44.5 in) in height; these height | ||||
| and weight measurements approximately | ||||
| correspond to that of an average 5 year old. | 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. | 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. | ||||
| Mode of Operation | Continuous operation with intermittent, | |||
| stated permissible loading | Continuous operation with intermittent, | |||
| stated permissible loading | Continuous operation with intermittent, | |||
| stated permissible loading | ||||
| 3D technology | CBCT Cone beam | CBCT Cone beam | CBCT Cone beam | |
| Computed Tomography | Computed Tomography | Computed Tomography | ||
| Performance Specification | 1) CBCT Computed tomography | 1) CBCT Computed tomography | 1) CBCT Computed tomography | |
| - Patient | - Patient | - Patient | ||
| - Dental Model Scan(Optional) | - Dental Model Scan(Optional) | - Dental Model Scan(Optional) | ||
| 2) Panoramic | 2) Panoramic | 2) Panoramic | ||
| 3) Cephalometric(optional) | 3) Cephalometric(optional) | 3) Cephalometric(optional) | ||
| - Scan type | - One shot type | - One shot type | ||
| - Scan type | ||||
| - Scan type | ||||
| Base | Base | Base | ||
| CT + PANO | CT + PANO | CT + PANO | ||
| Option(CEPH) | Option(CEPH) | Option(CEPH) | ||
| CT + PANO + SCAN CEPH | CT + PANO + SCAN CEPH | CT + PANO + SCAN CEPH | ||
| Functional Option | ||||
| CT + PANO + One shot(One shot, Standard | CT + PANO + One shot(One shot, Standard | |||
| Type) | Type) | |||
| CT + PANO + One shot(One shot, Large Type) | CT + PANO + One shot(One shot, Large Type) | |||
| CT | FXDD-1724R | FXDD-0606CA | FXDD-0606CA | |
| FXDD-1012CHA | Jupi0606X | |||
| PANO | FXDD-1724R | FXDD-0606CA | FXDD-0606CA | |
| Detector Type | FXDD-1012CHA | Jupi0606X | ||
| Ceph (Scan) | XID-C24DC | XID-C24DC | XID-C24DC | |
| Ceph (One shot) | N/A | 1717SCC | FXRD-1717VA | |
| N/A | PaxScan2530C | FXDD1012CA | ||
| Exposure switch Type | "Deadman" Button type | "Deadman" Button type | "Deadman" Button type | |
| Ceph Apparatus | Ceph Apparatus | Ceph Apparatus | ||
| Vertical Carriage | Vertical Carriage | Vertical Carriage | ||
| Rotator | Rotator | Rotator | ||
| X-RAY Generator | X-RAY Generator | X-RAY Generator | ||
| X-ray tube | X-ray tube | X-ray tube | ||
| High Frequency Generator | High Frequency Generator | High Frequency Generator | ||
| Column | Column | Column | ||
| Touch monitor (panel) | Touch monitor (panel) | Touch monitor (panel) | ||
| Detector | Detector | Detector | ||
| - CT | - CT | |||
| Main Components | FXDD-1724R | FXDD-0606CA | FXDD-0606CA | |
| FXDD-1012CHA | Jupi0606X | |||
| - PANO | - PANO | - PANO | ||
| FXDD-1724R | FXDD-0606CA | FXDD-0606CA | ||
| FXDD-1012CHA | Jupi0606X | |||
| - Ceph | - Ceph | -Ceph | ||
| XID-C24DC(Scan) | XID-C24DC(Scan) | XID-C24DC(Scan) | ||
| PaxScan 2530C(One shot, Standard Size) | FXDD-1012CA(One shot, Standard Size) | |||
| 1717SCC(One shot, Large Size) | FXRD-1717VA(Oneshot, Large Size) | |||
| Chinrest | Chinrest | Chinrest | ||
| Head rest | Head rest | Head rest | ||
| Automatic Collimator | Automatic Collimator | Automatic Collimator | ||
| Exposure switch | Exposure switch | Exposure switch | ||
| Emergency stop switch | Emergency stop switch | Emergency stop switch | ||
| Console PC set | Console PC set | Console PC set | ||
| CT exams | CT exams | CT exams | ||
| Automatic Collimator | Panoramic exams | Panoramic exams | Panoramic exams | |
| Cephalometric exams | Cephalometric exams | Cephalometric exams | ||
| Display Type | TFT LCD type(Normally black) | |||
| *1280x800 pixel | TFT LCD type(Normally black) | |||
| *1280x800 pixel | TFT LCD type(Normally black) | |||
| *1280x800 pixel | ||||
| Class | Class I with type B applied parts according to | |||
| IEC 60601-1 | Class I with type B applied parts according to | |||
| IEC 60601-1 | Class I with type B applied parts according to | |||
| IEC 60601-1 | ||||
| Focal size | 0.5(Patient/Model scan) | 0.5(Patient) | ||
| 0.04 (Model scan) | 0.5 | |||
| Field of View(CT) | Max. 180x160 mm | FXDD-0606CA : Max. 160x100 mm | ||
| FXDD-1012CHA : Max. 200x200 mm | Max. 160x100 mm | |||
| X-ray Voltage(Patient) | 60~100kVp | 60~100kVp | 60~100kVp | |
| X-ray Current(Patient) | 1~17mA | 4~17mA | 1~17mA | |
| X-ray Voltage(Model Scan, Optional) | N/A | 50~80kVp | N/A | |
| X-ray Current(Model Scan, Optional) | N/A | 0.4~0.7mA | N/A | |
| Total Filtration | Min. 2.8 mm Al equivalent | Min. 2.8 mm Al equivalent | Min. 2.8 mm Al equivalent | |
| Detector Pixel | ||||
| size | CT | FXDD-1724R : 95 μm | FXDD-0606CA : 119 μm | |
| FXDD-1012CHA : 124 μm | FXDD-0606CA : 119μm | |||
| Jupi0606X : 100 μm | ||||
| PANO | N/A | |||
| FXDD-1724R : 95 μm | FXDD-0606CA : 119 μm | |||
| FXDD-1012CHA : 124 μm | FXDD-0606CA : 119 μm | |||
| Jupi0606X : 100 μm | ||||
| Ceph (Scan) | XID-C24DC : 100 μm | XID-C24DC : 100 μm | XID-C24DC : 100 μm | |
| Ceph (One shot) | N/A | |||
| N/A | 1717SCC : 127 μm | |||
| PaxScan 2530C : 139 μm | FXRD-1717VA : 140 μm | |||
| FXDD-1012CA : 124 μm | ||||
| Magnification | CT | 1.44(Patient/Model scan) | 1.44(Patient) | |
| 1.91(Model Scan) | 1.44 | |||
| PANO | 1.35 | 1.3 | 1.31 | |
| Ceph (Scan) | 1.11 | 1.11 | 1.11 | |
| Ceph (One shot) | N/A | Standard Size : 1.12 | ||
| Large Size : 1.13 | Standard Size : 1.12 | |||
| Large Size : 1.13 | ||||
| N/A | ||||
| Scan time | CT: below 20sec (Patient/Model scan) | CT : below 20sec(Patient) | ||
| CT : below 180sec(Model Scan) | CT : below 14sec | |||
| Pano : below 14sec | Pano : below 14sec | Pano : below 14sec | ||
| Ceph(Scan) : below 20sec | Ceph[Scan type] : below 20sec | Ceph[Scan type] : below 20sec | ||
| N/A | Ceph[One shot type] : below 2sec | Ceph[One shot type] : below 2sec | ||
| Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | |
| Image Viewing Software | R2 STUDIO Q | RayScan | ||
| (Cleared under K192737) | RayScan | |||
| (Cleared under K182614) | ||||
| Image acquisition | Giga-Ethernet Network | Giga-Ethernet Network | Giga-Ethernet Network | |
| Total Height | Max 2,296mm | Max 2,296mm | Max 2,296mm | |
| Weight | 1) Computed Tomography(CT) + | |||
| Panoramic(PANΟ) = 240kg(529.1lb) ± 10% | 1) Computed Tomography(CT) + | |||
| Panoramic(PANΟ) = 189kg(416.6lb) ± 10% | 1) Computed Tomography(CT) + | |||
| Panoramic(PANΟ) = 185kg(407.9lb) ± 10% | ||||
| 2) Computed Tomography(CT) + | ||||
| Panoramic(PANΟ) + Ceph(Scan type) = | ||||
| 270kg(595.2lb) ± 10% | 2) Computed Tomography(CT) + | |||
| Panoramic(PANO) + Ceph(Scan type) = | ||||
| 219kg(482.8lb) ± 10% | 2) Computed Tomography(CT) + | |||
| Panoramic(PANO) + Ceph(Scan type) = | ||||
| 212.5kg(468.5lb) ± 10% | ||||
| 3) Computed Tomography(CT) + | ||||
| Panoramic(PANO) + Ceph(One shot type, | ||||
| installed in Standard size) = 217kg(478.4lb) ± 10% | 3) Computed Tomography(CT) + | |||
| Panoramic(PANO) + Ceph(One shot type, | ||||
| installed in Standard size) = 211kg(465.2lb) ± 10% | ||||
| 4) Computed Tomography(CT) + | ||||
| Panoramic(PANO) + Ceph(One shot type, | ||||
| installed in Large size) = 212kg(467.3lb) ± 10% | 4) Computed Tomography(CT) + | |||
| Panoramic(PANO) + Ceph(One shot type, | ||||
| installed in Large size) = 211kg(465.2lb) ± 10% | ||||
| Type of installation | Wall or floor mount | Wall or floor mount | Wall or floor mount | |
| Patient position | Standing / Wheelchair | Standing / Wheelchair | Standing / Wheelchair | |
| Face scan mode | Option | Option | NA | |
| Applicable Standards | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | |
| IEC 60601-1-2 | IEC 60601-1-3 | IEC 60601-1-3 | ||
| IEC 60601-1-3 | IEC 60601-2-63 | IEC 60601-2-63 | ||
| IEC 60601-2-63 | IEC 60601-1-2 | IEC 60601-1-2 |
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Similarities and differences
1. Similarities
The subject device has the same characteristic for the following compared to the predicate device
- Indication for use, mode of operation, 3D technology, performal option, exposure switch type, main components(except for detector), autonativ collimator, display type, class, fora voltage(patient), }-ray current(patient), total filtration, magnification(CT, Ceph), scan time, format compatible, image aquisition, total height, y installation, patient position, applicable standards
2. Differences
The subject device has the different characteristic for the following compared to the predicate device and reference device - Detector (using for CT, PANO), Field of view, magnification(PANO),Weight, Image Viewing Software
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12. Safety and Effectiveness Information
RCT820 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 fundamental technological characteristics of the subject and predicate device are similar. The imaging modes are similar; PANO, CEPH (Optional), CBCT, Model Scan.
The differences are as follows.
- Detector (using for CT, PANO), Field of view, magnification (PANO)
- Weight
- Image Viewing Software
These differences are explained not affecting on the substantial equivalence, also the subject device was verified with non-clinical performance test and clinical test. The test result supports that the subject device is substantially equivalent to the predicate device and the diffecting the substantial equivalence.
Biocompatibility Testing
The biocompatibility evaluation for RCT820 components was conducted in accordance with the FDA Guidance Document and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part1: Evaluation and Testing within a Risk Management Process ", as recognized by FDA.
The components of the RCT820 are considered surface medical device or external communicating medical device for a duration of less than 24 hours.
The biocompatibility testing was performed for Cytotoxicity, Skin sensitization and Irritation according to ISO 10993-5 and ISO 10993-10.
Electrical Safety and Electromagnetic compatibility (EMC)
The Electrical Safety and Electromagnetic compatibility were performed in accordance with the following standards.
- · IEC 60601-1:2005/AMD1:2012
- ・ IEC 60601-1-3:2008/AMD1:2013
- · IEC 60601-1-6:2010/AMD1:2013
- ・ IEC 60601-2-63:2017/AMD1:2017
- · IEC 60601-1-2: 2014
Software Validation
The software(named R2 STUDIO Q) used in the subject device has an imaging viewing option similar to the predicate devices software. Likewise, the software of RCT820 saves the patient and image data and offers an inquiry function. In addition, supports the image generate function intended to obtain images using the RCT820 equipment and various sensors for diagnosis. And that has been validated according to FDA "Guidance for the Contents of 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
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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.
Performance Test – Bench Test
Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - 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 61223-3-7.
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".
RCT820 is equipped with FXDD-1724R. FXDD-1724R is a new SSXI detector, which is used to capture an image in panoramic, CBCT. Sample images with a clinical evaluation report is provided to support the intended use of the device.
Based on Non-Clinical and Clinical Test results of FXDD-1724R for the subject device, is similar to that of the Jupi0606X for the reference device.
Pediatric Information
Pediatric information related to the use of this device is provided to users in compliance with FDA guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications".
13. 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. MegaGen Implant Co., Ltd. concludes that the newly RCT820 is safe and effective and substantially equivalent to the predicate devices as described herein.