(83 days)
RCT600 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus and TMJ structure for adult and pediatric patients. 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.
RCT600 provides 3D computed tomography for scanning hard tissues such as bone and teeth. By rotating the C-arm, which houses a high-voltage generator, an X-ray tube and a detector on each end, CBCT images of dental maxillofacial structures are obtained by recombining data scanned from the same level at different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a cephalometric option for obtaining cephalometric images.
The RCT600 device, for which K243903 is the 510(k) number, is a Computed Tomography X-Ray System used for radiographic examination of dento-maxillofacial, sinus, and TMJ structures. It also includes cephalometric imaging, specifically wrist images for growth and maturity assessment for orthodontic treatment.
The acceptance criteria are implicitly defined by the safety and effectiveness information provided in the 510(k) summary, specifically by demonstrating substantial equivalence to the predicate device, RCT700 (K213226). The testing performed aims to prove that despite some differences (deletion of one-shot Ceph option, different scan Ceph detector, changes in magnification, and scan times), the RCT600 maintains similar safety and effectiveness characteristics.
Here’s a breakdown of the information requested based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are based on demonstrating performance similar to the predicate device (RCT700, K213226) and meeting recognized international standards for medical electrical equipment and X-ray imaging devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Substantial Equivalence and Standards Compliance) | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Safety | Compliance with IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-63 standards. | Complied with listed IEC standards for electrical, mechanical, and environmental safety. |
| EMC | Compliance with IEC 60601-1-2 standard. | Complied with IEC 60601-1-2 for EMC testing. |
| Software Safety | Compliance with FDA Guidance for "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices". Software classified as "Basic Documentation Level" of concern. | Validated according to FDA guidance. Risk analysis of software determined the differences do not affect safety and effectiveness. |
| Image Quality (Non-Clinical) | Performance metrics (MTF, DQE, NPS) demonstrating no significant differences from predicate according to IEC 61223-3-4 and IEC 61223-3-7. | All test results satisfactory, indicating safety and effectiveness. Key image quality performance metrics (MTF, DQE, and NPS) demonstrated no significant differences between the two devices. |
| Diagnostic Quality (Clinical) | Generation of images of diagnostic quality for all dental modalities. | Sample clinical images for each dental modality were submitted and reviewed by a licensed practitioner, who deemed them to be of acceptable quality for the intended use. |
| Intended Use | Device performs as intended for radiographic examination of dento-maxillofacial, sinus, TMJ, and wrist for growth assessment. | Clinical testing confirmed the features of RCT600 (CBCT, panoramic, cephalometric acquisitions) worked as intended. |
| Technological Characteristics | Similar technological characteristics to the predicate (imaging modes, X-ray source, materials). | Fundamental technological characteristics are similar (PANO, CEPH (Optional), CBCT). Changes in magnification and scan times were noted but deemed not to affect safety/effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Sample clinical images" were submitted for each imaging dental modality and that features were "clinically tested." However, it does not specify the number of cases or patients used in the clinical imaging test set.
- Data Provenance: The document does not explicitly state the country of origin of the data. It mentions "Clinical images were gathered from all detectors of the RCT600 system." The applicant is Ray Co., Ltd., based in SOUTH KOREA. Given the context, it is reasonable to infer the data either originated from or was managed by the manufacturer. The study is prospective, as it involved gathering clinical images with the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: "A licensed practitioner" (singular) reviewed the sample clinical images.
- Qualifications of Experts: The expert was an "independent, licensed practitioner/clinician DDS/ABOMR."
- DDS stands for Doctor of Dental Surgery, indicating a dental professional.
- ABOMR stands for American Board of Oral and Maxillofacial Radiology, indicating specialization in dental and maxillofacial radiology. No years of experience are specified.
4. Adjudication Method for the Test Set
The document states, "A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the device intended use." This indicates a single-reader review without an explicit adjudication process defined for multiple readers.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document describes a "clinical testing" where sample images were reviewed by a single licensed practitioner to confirm diagnostic quality. There is no mention of human readers improving with or without AI assistance, as this is an imaging device, not an AI diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not directly applicable to the RCT600, as it is an X-ray imaging system, not an AI diagnostic algorithm. The "performance" being evaluated implicitly includes the algorithm within the imaging device that processes and reconstructs the images. The focus is on the imaging system's ability to produce diagnostically acceptable images for human interpretation. The clinical evaluation verifies the diagnostic quality of the images produced by the device, which is an assessment of its standalone imaging performance.
7. The Type of Ground Truth Used
The ground truth for the clinical image review was based on expert consensus (from the singular licensed practitioner) regarding the "acceptable quality for the device intended use" of the sample clinical images.
8. The Sample Size for the Training Set
The document does not specify a sample size for a training set. The device being described is an X-ray imaging system, not a machine learning algorithm that typically requires a separate training set. The "software" component mentioned underwent validation, but no details of training data for the software's inherent functions (e.g., image reconstruction algorithms) are provided, as these are typically validated through engineering and bench testing rather than a separate clinical "training set" in the context of device clearance.
9. How the Ground Truth for the Training Set was Established
As no explicit training set for an AI algorithm is mentioned, the concept of ground truth establishment for a training set is not applicable in the context of this device's submission description. The software validation relies on risk analysis and compliance with FDA guidance documents rather than a specific clinical training dataset and ground truth for learning.
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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.
March 12, 2025
RAY Co., Ltd. % Soo Ji Huh Official Correspondent 1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu Yongin-si, Gyeonggi-do 16882 SOUTH KOREA
Re: K243903
Trade/Device Name: RCT600 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: December 19, 2024 Received: December 19, 2024
Dear Soo Ji Huh:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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.
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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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological 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) K243903
Device Name RCT600
Indications for Use (Describe)
RCT600 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus and TMJ structure for adult and pediatric patients. 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) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K243903
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
December 19, 2024
| Applicant | Ray Co., Ltd. | |
|---|---|---|
| Address | 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si,16882, Korea | |
| Manufacturer | Name | Ray Co., Ltd. |
| Address | 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si,16882, Korea | |
| Tel | +82-31-605-1000 | |
| Fax | +82-2-6280-5534 | |
| Contact Person | Name | Sooji Huh |
| sooji.huh@raymedical.co.kr |
3. Administrative Information
4. Device Information
| Trade/Proprietary Name | RCT600 | |
|---|---|---|
| Common Name | Computed Tomography X-Ray System | |
| Classification Name | Device | X-ray tomography, computed, dental |
| Regulation Number | 21 CFR 892.1750 | |
| Class | 2 | |
| Product Code | OAS | |
| Review Panel | Radiology |
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5. Predicate device
| Parameter | Predicate Device | Parameter | Proposed Device | Predicate Device | |
|---|---|---|---|---|---|
| Device Name | RCT700 | Manufacturer | Ray Co., Ltd. | Ray Co., Ltd. | |
| Manufacturer | Ray Co., Ltd | Device name | RCT600 | RCT700 | |
| 510(K) Number | K213226 | 510(K) Number | (Traditional 510K) | K213226(Traditional 510K) | |
| Classificationname | Computed tomography x-ray system | Common Name | Computed Tomography X-RaySystem | Dental panoramic/tomography andcephalometric x-ray system | |
| Regulationnumber | 892.1750 | Indications for use | RCT600 is CBCT and panoramic x-ray imaging system withcephalometric. Which is intended toradiographic examination of thedento-maxillofacial, sinus and TMJstructure for diagnostic support foradult and pediatric patients.Cephalometric image is alsoincludes wrist to obtain carpusimages for growth and maturityassessment for orthodontictreatment.The device is to be operated andused by dentists or other legallyqualified heath care professionals | RCT700 is CBCT and panoramic x-ray imaging system withcephalometric. Which is intended toradiographic examination of thedento-maxillofacial, sinus, TMJ,Airway and ENT structure fordiagnostic support for adult andpediatric patients. And a model scanis included as an option.Cephalometric image is alsoincludes wrist to obtain carpusimages for growth and maturityassessment for orthodontictreatment. The device is to beoperated and used by dentists orother legally qualified health careprofessionals. | |
| Primary productcode | OAS | Mode of Operation | Same as predicate device #1 | Continuous operation withintermittent, stated permissibleloading | |
| 3D technology | Same as predicate device #1 | CBCT Cone beamComputed Tomography | |||
| Performance Specification | 1) CBCT Computed tomography2) Panoramic3) Cephalometric(optional)- Scan type | 1) CBCT Computed tomography- Patient2) Panoramic3) Cephalometric(optional)- One shot type- Scan type | |||
| Functional Option | BaseCT + PANOOption(CEPH)CT + PANO + SCAN CEPH | BaseCT+PANOOption(CEPH)CT + PANO + SCAN CEPHCT + PANO + One shot(One shot,Standard Type)CT + PANO + One shot(One shot,Large Type). | |||
| Detector | CT | N/A | FXDD-0606CA |
6. Device Description
RCT600 provides 3D computed tomography for scanning hard tissues such as bone and teeth. By rotating the C-arm, which houses a high-voltage generator, an X-ray tube and a detector on each end, CBCT images of dental maxillofacial structures are obtained by recombining data scanned from the same level at different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a cephalometric option for obtaining cephalometric images.
7. Indication for use
RCT600 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus and TMJ structure for diagnostic support for adult and pediatric patients. 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
8. Patient population
The patient population that may receive X-ray diagnostic radiation exposure includes individuals of any ethnic group, gender, weight, health status, or condition.
We recommend that patients who undergo X-ray diagnostic radiation exposure be over 5 years old.
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9. Comparison with predicate device
The following table provides the summary of the technological characteristics of RCT600 compared to the predicate device.
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| Type | |||
|---|---|---|---|
| PANO | Same as predicate device #1 | Jupi0606X1 | |
| N/A | FXDD-0606CA | ||
| PANO | Same as predicate device #1 | Jupi0606X1 | |
| Ceph (Scan) | Pluto0900X | XID-C24DC | |
| Ceph (One shot) | N/A | FXRD-1717VA | |
| N/A | FXDD-1012CA | ||
| Exposure switch Type | Same as predicate device #1 | "Deadman" Button type | |
| Same as predicate device #1 | Ceph Apparatus | ||
| Same as predicate device #1 | Vertical Carriage | ||
| Same as predicate device #1 | Rotator | ||
| Same as predicate device #1 | X-RAY Generator | ||
| Same as predicate device #1 | X-ray tube | ||
| Same as predicate device #1 | High Frequency Generator | ||
| Main Components | Same as predicate device #1 | Column | |
| Control panel | Touch monitor (panel) | ||
| Detector | Detector | ||
| -CT | -CT | ||
| Jupi0606X1 | FXDD-0606CA | ||
| -PANO | Jupi0606X1 | ||
| Jupi0606X1 | -PANO | ||
| -Ceph | FXDD-0606CA | ||
| Pluto0900X(Scan) | Jupi0606X1 | ||
| Same as predicate device #1 | -Ceph | ||
| Temple support | XID-C24DC(Scan)FXRD-1717VA(One shot, LargeSize)FXDD-1012CA(One shot, StandardSize) | ||
| Same as predicate device #1 | Chinrest | ||
| Temple support | Head rest | ||
| Same as predicate device #1 | Automatic Collimator | ||
| Same as predicate device #1 | Exposure switch | ||
| Same as predicate device #1 | Emergency stop switch | ||
| Automatic Collimator | N/A | Console PC set | |
| Same as predicate device #1 | CT examsPanoramic examsCephalometric exams | ||
| Class | Same as predicate device #1 | Class I with type B applied parts according to IEC 60601-1 | |
| Focal size | Same as predicate device #1 | 0.5 | |
| Field of View(CT) | Same as predicate device #1 | Max. 160x100 mm | |
| X-ray Voltage | Same as predicate device #1 | 60~100kVp | |
| X-ray Current | Same as predicate device #1 | 1~17mA | |
| Total Filtration | Same as predicate device #1 | Min. 2.8 mm Al equivalent | |
| DetectorPixel size | CT | N/A | FXDD-0606CA: 119µm |
| Same as predicate device #1 | Jupi0606X1 : 100µm | ||
| PANO | N/A | FXDD-0606CA: 119µm | |
| Same as predicate device #1 | Jupi0606X1 : 100µm | ||
| Ceph (Scan) | Pluto0900X: 100µm | XID-C24DC: 100µm | |
| Ceph(Oneshot) | N/A | FXRD-1717VA : 140µm | |
| N/A | FXDD-1012CA : 124µm | ||
| Magnification | CT | 1.55 | 1.44 |
| PANO | 1.44 | 1.31 | |
| Ceph (Scan) | Same as predicate device #1 | 1.11 | |
| Ceph(Oneshot) | N/A | Large Type: 1.13 | |
| N/A | Standard Type: 1.12 | ||
| Scan time | CT : below 20sec | CT : below 14sec | |
| Same as predicate device #1 | Pano : below 14sec | ||
| Ceph[Scan size] : below 17.6sec | Ceph[Scan size]: below 20sec | ||
| N/A | Ceph [One shot size]: below 2 sec | ||
| Format compatible | Same as predicate device #1 | DICOM 3.0 Format compatible | |
| Image Viewing Software | SMARTScam | RayScan | |
| Image acquisition | Same as predicate device #1 | Giga-Ethernet Network | |
| Total Height | Max 2,288mm | Max 2,296mm |
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| Weight | 1) Computed Tomography (CT) +Panoramic(PANO)=196kg(432.1lb) ±10%2) Computed Tomography (CT) +Panoramic(PANO) + Ceph (Scantype)= 217kg (478.4lb) ± 10% | 1) Computed Tomography (CT) +Panoramic (PANΟ)=185kg(407.9lb) ±10%2) Computed Tomography (CT) +Panoramic(PANO) + Ceph (Scantype)= 212.5kg (468.5lb) ± 10%3) Computed Tomography (CT) +Panoramic(PANO) + Ceph (Oneshot type, installed in Standardsize)= 211kg (465.2lb) ± 10%4) Computed Tomography (CT) +Panoramic(PANO) + Ceph (Oneshot type, installed in Large size)211kg (465.2lb) ± 10% |
|---|---|---|
| Type of installation | Same as predicate device #1 | Wall or floor mount |
| Patient position | Same as predicate device #1 | Standing / Wheelchair |
| Applicable Standards | Same as predicate device #1 | IEC 60601-1IEC 60601-1-3IEC 60601-2-63IEC 60601-1-2 |
The product is principally just the same as in the previous 510(k) #K213226
The complete of differences of the subject device to the predicate device #K213226 is as follows
-
Delete of the One-shot Ceph Option
-
Detector (using Scan Ceph)
-
The magnification of CT and Panorama has been changed from 1.44 and 1.31 to 1.55 and 1.44
-
The CT, Scan ceph scan time has been changed from 14sec and 20sec to 20sec and 17.6sec
-
Change of the Image viewing software
However, X-ray voltage, X-ray current, and CT, Pano detector was identified in #K213226.
The 510(k) for the existing detector used in our equipment is provided below.
| Modality | Detector Model | Cleared | 510(k) No. |
|---|---|---|---|
| CT | Jupi0606X1 | No PMA | K213226 |
| Pano | Jupi0606X1 | No PMA | K213226 |
| Scan Ceph | Pluto0900X | No PMA | K211159 |
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10. Safety and Effectiveness Information
The RCT600 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 substantiates the substantial equivalence between the subject device and predicate device. The fundamental technological characteristics of the subject and predicate devices are similar. The imaging modes are similar; PANO, CEPH (Optional), CBCT. 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 predicate devices 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.
- Delete of the One-shot Ceph Option
- Detector (using Scan Ceph).
- The magnification of CT and Panorama has been changed from 1.44 and 1.31 to 1.55 and 1.44
- The CT, Scan ceph scan time has been changed from 14sec and 20sec to 20sec and 17.6sec
- Change of the Image viewing software
However, X-ray voltage, X-ray current, and CT, Pano detector was identified in #K213226.
Electrical, mechanical and environmental safety testing according to the standard of IEC 60601-1:2005/AMD1:2020 (3.2 Edition), IEC 60601-1-3:2008/AMD1:2013/AMD2:2021 (2.2 Edition), IEC 60601-1-6:2010/AMD1:2013/AMD2:2020 (3.2 Edition), and IEC 60601-2-63:2012/AMD1:2017/AMD2:2021 (1.2 Edition) were performed.
EMC testing was conducted in accordance with the standard IEC 60601-1-2:2014+AMD1:2020 (Edition 4.1).
The software of RCT600 saves patient and image data and offers an inquiry function. In addition, it supports the image generate function intended to obtain images using the RCT600 equipment and various sensors for diagnosis. That has been validated according to the FDA Guidance for the "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" to assure substantial equivalence. The software for this device was considered a "Basic Documentation 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 a 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 the FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices". Bench testing is used to assess whether the x-ray exposure parameters are adequate to generate images of diagnostic quality.
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Testing for Imaging Performance was conducted according to the recognized standards IEC 61223-3-4 and IEC 61223-3-7. Key imaqe quality performance metrics such as MTF, DQE, and NPS demonstrated that there are no significant differences between the two devices. All test results are satisfactory and they indicate safety and effectiveness for the dental system RCT600.
Non-clinical considerations were conducted in accordance with the FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices." Because the subject device uses the same detector as the predicate device, there are no significant differences between the two devices as a result of non-clinical testing.
Clinical testing was conducted according to the FDA Document "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices". Sample clinical images were submitted for each imaging dental modality, and they provide evidence to show that the RCT600 works as intended while generating images of diagnostic quality.
The features of RCT600 (including CBCT, panoramic, and cephalometric acquisitions) were clinically tested and approved by an independent, licensed practitioner/clinician DDS/ABOMR). Clinical images were gathered from all detectors of the RCT600 system using recognized protocols for image acquisition. A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the device intended use.
11. 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 RCT600 is safe, effective and substantially equivalent to the predicate device as described herein.
§ 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.