(25 days)
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 health care professionals.
The system's purpose is RCT800, a 3D computed tomography scanner for scanning hard tissues like bones and teeth. By rotating the c-arm, which is embedded with an all-in-one x-ray tube and a detector on each end, CBCT images of the dental maxillofacial area can be attained by recombining data from the same level that is scanned from different angles. Additionally, the system includes a panoramic image scanning function for attaining images of the whole teeth, a cephalometric scanning option for attaining a cephalic image, and a Model Scan option for attaining a dental model CBCT image.
The provided text describes the 510(k) summary for the Ray Co., Ltd.'s RCT800 device. While it mentions various tests and compliance with standards, it does not explicitly provide a table of acceptance criteria and reported device performance in the typical format of a clinical study report with specific metrics and thresholds. Instead, it states that "All test results were satisfactory" for performance (imaging performance) testing conducted according to IEC 61223-3-4 and IEC 61223-3-7.
It also mentions "Clinical images were provided" and that "A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use," but it doesn't detail a formal clinical study with specific acceptance criteria beyond subjective expert opinion.
Therefore, much of the requested information regarding the study that proves the device meets the acceptance criteria in a quantifiable manner (e.g., statistical significance, specific performance numbers) is not present in the provided document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technical similarities, bench testing, and compliance with general safety and performance standards.
However, based on the provided text, I can infer and extract some information:
Acceptance Criteria and Device Performance (Inferred from compliance statements)
Since the document states that "All test results were satisfactory" for imaging performance tests and that a licensed practitioner found clinical images to be of "acceptable quality for the intended use," the implied acceptance criteria were met. However, the specific quantitative criteria are not listed.
Table 1: Implied Acceptance Criteria and Reported Device Performance
| Criterion Category | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Imaging Performance | Parameters required to describe functionalities related to imaging properties satisfy designated tolerance (as per IEC 61223-3-4 and IEC 61223-3-7). | "All test results were satisfactory." (No specific quantitative results provided) |
| Clinical Image Quality | Sample clinical images are of acceptable quality for the intended use by a licensed practitioner. | "A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use." (Qualitative assessment) |
| Electrical, Mechanical & Environmental Safety | Conformity to 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). | "Electrical, mechanical and environmental safety testing... were performed." (Implied satisfactory outcome as part of substantial equivalence) |
| EMC | Conformity to IEC 60601-1-2:2014 (Edition 4.0). | "EMC testing was conducted in accordance with the standard IEC 60601-1-2:2014 (Edition 4.0)." (Implied satisfactory outcome as part of substantial equivalence) |
| Software Validation | Compliance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" for moderate level of concern. | "That has been validated according to the FDA 'Guidance...'" and "...assure substantial equivalence." "Based on our risk analysis of software, the difference does not affect its safety and effectiveness." (Implied successful validation and no safety/effectiveness issues due to software) |
Study Details (Based on the provided text)
-
Sample sizes used for the test set and the data provenance:
- Test Set (Clinical Images): The document states "Clinical imaging samples were collected from new detectors on the proposed device at the two offices where the predicate device was installed for the clinical test images. These images were gathered from all detectors installed with RCT800 using protocols with random patient age, gender, and size."
- Specific Number: Not specified. It indicates "samples" and "images gathered from all detectors," implying a collection across multiple patient demographics, but no numerical count is provided.
- Provenance: Clinical images obtained from "two offices where the predicate device was installed." The country of origin is not explicitly stated for these clinical images, but the applicant (Ray Co., Ltd.) is from SOUTH KOREA, so it is plausible these were collected within South Korea or countries where the predicate device was installed.
- Retrospective/Prospective: Not explicitly stated, but the mention of collecting "new detectors" and "random patient age, gender, and size" suggests some form of prospective or concurrent collection for evaluation.
- Test Set (Clinical Images): The document states "Clinical imaging samples were collected from new detectors on the proposed device at the two offices where the predicate device was installed for the clinical test images. These images were gathered from all detectors installed with RCT800 using protocols with random patient age, gender, and size."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Two licensed practitioners/clinicians" clinically tested and approved the features. "A licensed practitioner reviewed the sample clinical images." It's unclear if these refer to the same "two" or one specific "licensed practitioner."
- Qualifications: "Licensed practitioners/clinicians." No further details on their years of experience, subspecialty (e.g., specific type of radiologist/dentist), or formal board certifications are provided.
-
Adjudication method (e.g., 2+1, 3+1, none) 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 intended use." This suggests a qualitative assessment, but no formal adjudication method (like 2+1 consensus) is described. It implies that the single or (if two practitioners were involved) potentially un-adjudicated opinion of the expert(s) served as the "truth."
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was mentioned. The document focuses on demonstrating that the device itself produces images of acceptable quality for human interpretation, not on the improvement of human readers with AI assistance. This device is a source of images (an X-ray system), not an AI algorithm for image analysis.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a medical imaging system (CT/panoramic/cephalometric X-ray system), not an AI algorithm for image analysis. Therefore, the concept of "standalone performance" for an algorithm does not apply in the context of this device. The performance refers to the image acquisition capabilities of the system itself.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For clinical image quality, the ground truth was expert opinion/assessment by "licensed practitioners/clinicians" who deemed the images "of acceptable quality for the intended use."
- For bench testing, the ground truth was based on compliance with standards (e.g., IEC 61223-3-4, IEC 61223-3-7) and "designated tolerance" parameters.
-
The sample size for the training set:
- This device is an X-ray imaging system. It takes images (presumably raw data) and reconstructs them into clinically useful images using reconstruction algorithms such as FBP (Filtered Back Projection) (as mentioned for the predicate device). The document does not describe the use of machine learning that would require a "training set" in the conventional AI sense. If any internal algorithms are adaptable or "learn," details are not provided. The phrase "training set" is typically applicable to AI/ML devices, which this is not identified as in the provided text.
-
How the ground truth for the training set was established:
- Not applicable, as no training set (for AI/ML) is mentioned or implied for this device.
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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.
April 11, 2023
Ray Co., Ltd. % Changhwan Lee RA Manager 1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu Yongin-si, Gyeonggi-do 16882 SOUTH KOREA
Re: K230753
Trade/Device Name: RCT800 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: March 15, 2023 Received: March 17, 2023
Dear Changhwan Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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. 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 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) K230753
Device Name RCT800
Indications for Use (Describe)
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric.
Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option.
Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified health care professionals.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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K230753 510(k) Summary
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
March 6, 2023
| 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 | Changhwan Lee |
| ch0406.lee@raymedical.co.kr |
3. Administrative Information
4. Device Information
| Trade/Proprietary Name | RCT800 | |
|---|---|---|
| Common Name | Dental Panoramic/Tomography and Cephalometric X-raySystem | |
| ClassificationName | Device | X-ray tomography, computed, dental |
| RegulationNumber | 21 CFR 892.1750 | |
| Class | 2 | |
| Product Code | OAS | |
| Review Panel | Radiology |
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| Parameter | Predicate Device-1 | Predicate Device-2 | |
|---|---|---|---|
| Device Name | RCT800 | RCT700 | |
| Manufacturer | Ray Co., Ltd | Ray Co., Ltd | |
| 510(K) Number | K192737 | K213226 | |
| Classificationname | Computed tomography x-ray system | Computed tomography x-ray system | |
| Regulationnumber | 892.1750 | 892.1750 | |
| Primary productcode | OAS | OAS | |
| Parameter | Proposed Device | Predicate Device-1 | Predicate Device-2 |
| Manufacturer | Ray Co., Ltd. | Ray Co., Ltd. | Ray Co., Ltd. |
| Device name | RCT800 | RCT800 | RCT700 |
| 510(K) Number | (Special 510K) | K192737(Traditional 510K) | K213226(Traditional 510K) |
| Common Name | Dental panoramic/tomography andcephalometric x-ray system | Dental panoramic/tomography andcephalometric x-ray system | Dental panoramic/tomography andcephalometric x-ray system |
| Indications for use | RCT800 is CBCT and panoramic x-rayimaging system with cephalometric.Which is intended to radiographicexamination of the dento-maxillofacial,sinus, TMJ, Airway for diagnosticsupport for adult and pediatric patients.And a model scan is included as anoption.Cephalometric image is also includeswrist to obtain carpus images for growthand maturity assessment for orthodontictreatment.The device is to be operated and usedby dentists or other legally qualifiedhealth care professionals. | RCT800 is CBCT and panoramic x-rayimaging system with cephalometric.Which is intended to radiographicexamination of the dento-maxillofacial,sinus, TMJ, Airway for diagnosticsupport for adult and pediatric patients.And a model scan is included as anoption.Cephalometric image is also includeswrist to obtain carpus images for growthand maturity assessment for orthodontictreatment.The device is to be operated and usedby dentists or other legally qualifiedhealth care professionals. | RCT700 is CBCT and panoramic x-rayimaging system with cephalometric.Which is intended to radiographicexamination of the dento-maxillofacial,sinus, TMJ, Airway and ENT structurefor diagnostic support for adult andpediatric patients. And a model scan isincluded as an option. Cephalometricimage is also includes wrist to obtaincarpus images for growth and maturityassessment for orthodontic treatment.The device is to be operated and usedby dentists or other legally qualifiedhealth 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 beamComputed Tomography | Same as predicate device #1 |
| reconstruction algorithm | Same as predicate device #1 | FBP(Filtered Back Projection) | Same as predicate device #1 |
5. Predicate device
6. Device Description
The system's purpose is RCT800, a 3D computed tomography scanner for scanning hard tissues like bones and teeth. By rotating the c-arm, which is embedded with an all-in-one x-ray tube and a detector on each end, CBCT images of the dental maxillofacial area can be attained by recombining data from the same level that is scanned from different angles. Additionally, the system includes a panoramic image scanning function for attaining images of the whole teeth, a cephalometric scanning option for attaining a cephalic image, and a Model Scan option for attaining a dental model CBCT image.
7. Indication for use
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option.
Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified heath care professionals.
8. Patient population
This device is intended to acquire diagnostic x-ray images of adult and pediatric individuals/patients without restriction on 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 RCT800 compared to the predicate device.
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| Performance Specification | 1) CBCT Computed tomography- Patient- Dental Model Scan(Optional)2) Panoramic3) Cephalometric(optional)- One shot type- Scan type | 1) CBCT Computed tomography- Patient2) Panoramic3) Cephalometric(optional)- One shot type- Scan type | |||
|---|---|---|---|---|---|
| Functional Option | BaseCT+PANOOption(CEPH)CT + PANO + SCAN CEPHCT + PANO + One shot(One shot,Standard Type)CT + PANO + One shot(One shot,Large Type). | Same as predicate device #1 | |||
| DetectorType | CT | FXDD-1724RA | FXDD-0606CA | Same as predicate device #1 | |
| Same as predicate device #1 | FXDD-1012CHA | Jupi0606X | |||
| PANO | FXDD-1724RA | FXDD-0606CA | Same as predicate device #1 | ||
| Same as predicate device #1 | FXDD-1012CHA | Jupi0606X | |||
| DetectorType | Ceph (Scan) | Same as predicate device #1 | XID-C24DC | Same as predicate device #1 | |
| Ceph (One shot) | Same as predicate device #2 | 1717SCC | FXRD-1717VA | ||
| Same as predicate device #2 | PaxScan 2530C | FXDD-1012CA | |||
| 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 |
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| Automatic Collimator | Same as predicate device #1 | CT examsPanoramic examsCephalometric exams | Same as predicate device #1 | ||||
|---|---|---|---|---|---|---|---|
| Same as predicate device #1 | Vertical Carriage | Same as predicate device #1 | Display Type | Same as predicate device #1 | TFT LCD type(Normally black)*1280x800 pixel | Same as predicate device #1 | |
| Same as predicate device #1 | Rotator | Same as predicate device #1 | Class | Same as predicate device #1 | Class I with type B applied partsaccording to IEC 60601-1 | Same as predicate device #1 | |
| Same as predicate device #1 | X-RAY Generator | Same as predicate device #1 | Focal size | Same as predicate device #2 | Patient 0.5Model scan 0.04 (Optional) | 0.5 | |
| Same as predicate device #1 | X-ray tube | Same as predicate device #1 | Field of View(CT) | FXDD-1724RA : Max.180x160 mmFXDD-1012CHA : Max. 200x200 mm | FXDD-0606CA : Max.160x100 mmFXDD-1012CHA : Max. 200x200 mm | Max. 160x100 mm | |
| Same as predicate device #1 | High Frequency Generator | Same as predicate device #1 | X-ray Voltage | Same as predicate device #1 | 60~100kVp | Same as predicate device #1 | |
| Same as predicate device #1 | Column | Same as predicate device #1 | X-ray Current | Same as predicate device #2 | 4~17mA | 1~17mA | |
| Same as predicate device #1 | Touch monitor (panel) | Same as predicate device #1 | Total Filtration | Same as predicate device #1 | Min. 2.8 mm Al equivalent | Same as predicate device #1 | |
| Detector-CTFXDD-1724RAFXDD-1012CHA-PANOFXDD-1724RAFXDD-1012CHA-CephXID-C24DC(Scan)FXRD-1717VA(Oneshot, Large Size)FXDD-1012CA(One shot, StandardSize) | Detector- CTFXDD-0606CAFXDD-1012CHA- PANOFXDD-0606CAFXDD-1012CHA- CephXID-C24DC(Scan)1717SCC(One shot, Large Size)PaxScan 2530C(One shot, StandardSize) | Detector-CTFXDD-0606CAJupi0606X-PANOFXDD-0606CAJupi0606X-CephXID-C24DC(Scan)FXRD-1717VA(Oneshot, Large Size)FXDD-1012CA(One shot, StandardSize) | DetectorPixel size | CT | FXDD-1724RA: 95µm | FXDD-0606CA: 119µm | Same as predicate device #1 |
| Same as predicate device #1 | Chinrest | Chinrest | Same as predicate device #1 | FXDD-1012CHA: 124µm | Jupi0606X : 100µm | ||
| Same as predicate device #1 | Head rest | Head rest | PANO | FXDD-1724RA: 95µm | FXDD-0606CA: 119µm | Same as predicate device #1 | |
| Same as predicate device #1 | Automatic Collimator | Automatic Collimator | Same as predicate device #1 | FXDD-1012CHA: 124µm | Jupi0606X : 100µm | ||
| Same as predicate device #1 | Exposure switch | Exposure switch | Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 100µm | Same as predicate device #1 | |
| Same as predicate device #1 | Emergency stop switch | Emergency stop switch | Ceph(One shot) | Same as predicate device #2 | 1717SCC: 127µm | FXRD-1717VA : 140µm | |
| Same as predicate device #1 | Console PC set | Console PC set | Same as predicate device #2 | PaxScan 2530C: 139µm | FXDD-1012CA : 124µm | ||
| Magnification | CT | Same as predicate device #2 | 1.44(Patient)1.91(Model Scan) | 1.44 | |||
| PANO | Same as predicate device #2 | 1.3 | 1.31 | ||||
| Ceph (Scan) | Same as predicate device #1 | 1.11 | Same as predicate device #1 | ||||
| Ceph(One shot) | Same as predicate device #1 | Large Type: 1.13 | Same as predicate device #1 |
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| Same as predicate device #1 | Standard Type: 1.12 | Same as predicate device #1 | ||
|---|---|---|---|---|
| Scan time | CT : below 20sec | CT : below 20sec(Patient)CT : below 180sec(Model Scan) | CT : below 14sec | |
| Same as predicate device #1 | Pano : below 14sec | Same as predicate device #1 | ||
| Same as predicate device #2 | Ceph[Scan size] : below 19sec | Ceph[Scan size] : below 20sec | ||
| Same as predicate device #1 | Ceph[One shot size]: 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 | RayScan(Cleared under K192737) | RayScan(Cleared under K192737) | RayScan(Cleared under K182614) | |
| 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)=189kg(416.6lb) ±10% | 1) Computed Tomography(CT) +Panoramic(PANO)=185kg(407.9lb) ±10% | |||
| Weight | Same as predicate device #1 | 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 Standardsize)= 217kg (478.4lb) ± 10% | 3) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Standardsize)= 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 |
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| Patient position | Same as predicate device #1 | Standing / Wheelchair | Same as predicate device #1 |
|---|---|---|---|
| Applicable Standards | Same as predicate device #1 | IEC 60601-1IEC 60601-1-3IEC 60601-2-63IEC 60601-1-2 | Same as predicate device #1 |
The product is principally just the same as in the previous 510(k) #K192737 and #K213226.
The complete of differences of the subject device to the predicate device #K192737 is as follows
-
The minimum X-ray current of the tube has been changed from 4mA to 1mA
-
The Magnification of Panorama has been changed from 1.3 to 1.31
-
Detector (using for CT, Pano, One-shot Ceph), Field of view.
However, X-ray current, magnification and one-shot ceph 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 | FXDD-1724RA | No PMA | K222219 |
| FXDD-1012CHA | No PMA | K182805 | |
| Pano | FXDD-1724RA | No PMA | K222219 |
| FXDD-1012CHA | No PMA | K182805 | |
| Scan Ceph | XID-C24DC | No PMA | K181452 |
| One shot Ceph | FXRD-1717VA | No PMA | K213226 |
| One shot Ceph | FXDD-1012CA | No PMA | K213226 |
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10. Safety and Effectiveness Information
The RCT800 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. All viewing software programs have been cleared with previous 510k submissions; RAYSCAN (K192737). 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.
- The minimum X-ray current of the tube has been changed from 4mA to 1mA
- The Magnification of Panorama has been changed from 1.3 to 1.31
- Detector (using for CT, Pano and One-shot Ceph), Field of view.
However, X-ray current, magnification and one-shot ceph detector was identified in #K213226.
Electrical, mechanical and environmental safety testing according to the 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 RCT800 saves patient and image data and offers an inquiry function. In addition, it supports the image generate function intended to obtain images using the RCT800 equipment and various sensors for diagnosis. That has been validated according to the FDA "Guidance for the Content 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 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 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 "Format for Traditional and Abbreviated 510(k)s," Section 18, "Performance Testing - Bench." Bench testing is used to assess whether the parameters required to describe functionalities related to imaging properties of the dental X-ray device and patient dosage satisfy the designated tolerance.
Performance (Imaging performance) testing was conducted according to the standards of IEC 61223-3-4 and IEC 61223-3-7. All test results were satisfactory.
Non-clinical considerations were conducted in accordance with the FDA Guidance
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"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 considerations were conducted according to the FDA Guidance "Format for Traditional and Abbreviated 510(k)s," Section 20. Clinical images were provided, and while these images were not necessary to establish substantial equivalence based on the modifications to the device, they provide further evidence, in addition to the laboratory performance data, to show that the complete system works as intended.
The features of RCT800 were clinically tested and approved by two licensed practitioners/clinicians. Clinical imaging samples were collected from new detectors on the proposed device at the two offices where the predicate device was installed for the clinical test images. These images were gathered from all detectors installed with RCT800 using protocols with random patient age, gender, and size. A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the 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 RCT800 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.