(61 days)
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 pediatic 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 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that are scanned from different angle. Panoramic image scanning function for attaining image of whole teeth, cephalometric scanning option for attaining cephalic image, and Model Scan option for attaining dental model CBCT image are included.
The provided text describes the updated RCT700 device, a dental panoramic/tomography and cephalometric X-ray system, and compares it to two predicate devices (K182614 and K192737). The 510(k) summary focuses on demonstrating substantial equivalence rather than a detailed study proving novel acceptance criteria for a new AI component. The acceptance criteria and the study conducted are primarily focused on maintaining safety and effectiveness comparable to the predicate devices.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to the performance specifications of the predicate devices and general regulatory standards for medical imaging devices. The "reported device performance" refers to the new device (RCT700) meeting these established specifications.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices and Standards) | Reported Device Performance (RCT700) |
|---|---|---|
| X-ray Current (Min.) | 4mA (from predicate) | Changed to 1mA (This represents a design change, and its safety/effectiveness is justified by non-clinical testing and comparison to standards) |
| Irradiation Time (One shot Ceph) | Not explicitly stated, but "changed" from predicate | Changed (details not provided, but deemed acceptable via non-clinical testing) |
| Electrical Safety | Compliance with IEC 60601-1: 2005/AMD1:2012(3.1 Edition) | Performed, results satisfactory |
| Protective Provisions against X-radiation | Compliance with IEC 60601-1-3: 2008/AMD1:2013(Second Edition) | Performed, results satisfactory |
| Usability | Compliance with IEC 60601-1-6:2010(Third Edition) | Performed, results satisfactory |
| Dental X-ray Equipment Specific | Compliance with IEC 60601-2-63: 2012/AMD1:2017(First Edition) | Performed, results satisfactory |
| EMC Testing | Compliance with IEC 60601-1-2: 2014(Edition 4.0) | Performed, results satisfactory |
| Software Validation | Compliance with FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" | Validated, deemed substantially equivalent with a "moderate" level of concern. |
| Imaging Performance | Compliance with IEC 61223-3-4 and IEC 61223-3-5 | Performed, all test results satisfactory |
| Non-clinical Performance | No significant difference compared to predicate device using the same detector | Demonstrated, as the subject device uses the same detector as the predicate. |
| Clinical Image Quality | Acceptable quality for intended use | Sample clinical images reviewed by a licensed practitioner and found acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the test set used for non-clinical or clinical evaluations.
- Test Set Description: "Bench testing" and "Performance (Imaging performance) testing" were conducted. "Clinical images were provided," and "clinical imaging samples are collected from the all detector on propose device at the 2 offices where the predicate device is installed."
- Data Provenance: The general context of the submission implies that the testing was conducted by the manufacturer (RAY Co., Ltd.) in REPUBLIC OF KOREA. The clinical images were collected from "2 offices where the predicate device is installed," suggesting a retrospective collection for evaluation purposes, though this isn't explicitly stated as purely retrospective vs. prospectively gathered for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: "two licensed practitioners/clinicians" for clinical testing. For the review of clinical images, "A licensed practitioner reviewed the sample clinical images."
- Qualifications of Experts: "licensed practitioners/clinicians." No specific experience level (e.g., "radiologist with 10 years of experience") is provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method like 2+1 or 3+1 for resolving discrepancies in expert opinions. It states that "A licensed practitioner reviewed the sample clinical images and found them to be of acceptable quality," suggesting a single-reader assessment for acceptance of image quality. For the "two licensed practitioners/clinicians" for clinical testing, the method of their "approval" is not detailed.
5. 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
- MRMC Study: No, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or described.
- AI Effect Size: The document does not describe AI functionality or an AI component that would require such a study or an effect size. The device is an imaging system, and its software (RayScan) is described as "viewing software programs" and supporting "image generate function," which is not characterized as AI for diagnostic assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device is a physical X-ray imaging system, not a standalone algorithm. The software (RayScan) is integrated into the device for image generation and viewing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the clinical image quality evaluation, the "ground truth" was established by the subjective assessment of "licensed practitioners" determining if the images were of "acceptable quality for the intended use." This aligns with expert opinion/assessment of image quality rather than objective ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device (an X-ray system) and its associated software (for image acquisition and viewing), not a machine learning or AI algorithm that would typically require a separate training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a machine learning or AI algorithm requiring a training set in this submission.
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November 29, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
RAY Co., Ltd % Ms. Youna Im RA Assistant Manager 332-7. Samsung 1-ro Hwaseong-si. 18380 REPUBLIC OF KOREA
Re: K213226
Trade/Device Name: RCT700 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: September 27, 2021 Received: September 29, 2021
Dear Ms. Im:
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 and Part 809); 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 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,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K213226
Device Name RCT700
Indications for Use (Describe)
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 pediatic patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified heath care professionals
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20)
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5. 510(K) Summary
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510(k) Summary
K213226
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.
-
- Date: September 27, 2021
3. Administrative Information
| APPLICANT | RAY Co.,Ltd |
|---|---|
| ADDRESS | #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 18380, Korea |
| Manufacturer | RAY Co.,Ltd332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 18380, Korea |
| TEL : +82-31-605-1000FAX : +82-2-6280-5534 | |
| Contact Person | e-mail : youna.im@raymedical.co.kr |
4. Device Information
Device Name
Trade/Proprietary Name: RCT700 Common Name: Dental panoramic/tomography and cephalometric x-ray system
Classification
Classification Name: Computed tomography x-ray system Regulation Number : 21 CFR 892.1750 Class : Il Product code : OAS Panel : Radiology
5. Predicate device
| Parameter | Predicate Device-1 | Predicate Device-1 |
|---|---|---|
| Device Name | RCT700 | RCT800 |
| Manufacturer | RAY Co., Ltd | RAY Co., Ltd |
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| 510(K) Number | K182614 | K192737 |
|---|---|---|
| Classification name | Computed tomography x-ray system | Computed tomography x-ray system |
| Regulation number | 892.1750 | 892.1750 |
| Primary productcode | OAS | OAS |
7. Device Description
System purpose RCT700 is 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that are scanned from different angle.
Panoramic image scanning function for attaining image of whole teeth, cephalometric scanning option for attaining cephalic image, and Model Scan option for attaining dental model CBCT image are included.
8. Indication for use
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
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.
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10. Comparison with predicate device
| Parameter | Proposed Device | Predicate Device-1 | Predicate Device-2 | |
|---|---|---|---|---|
| Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | |
| Device name | RCT700 | RCT700 | RCT800 | |
| 510(K) Number | (Traditional 510K) | K182614(Special 510K) | K192737(Traditional 510K) | |
| CommonName | Dental panoramic/tomography andcephalometric x-ray system | Dental panoramic/tomography andcephalometric x-ray system | Dental panoramic/tomography andcephalometric x-ray system | |
| Indicationsfor use | 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 qualifiedheath care professionals | RCT700, panoramic x-ray imagingsystem with cephalostat, is an extraoralsource x-ray system, which is intendedfor dental radiographic examination ofthe teeth, jaw, and oral structures,specifically for panoramic examinationsand implantology and for TMJ studiesand cephalometry, and it has thecapability, using the CBVT technique, togenerate dento-maxillo-facial 3Dimages. The device uses cone shapedx-ray beam projected on to a flat paneldetector, and the examined volumeimage is reconstructed to be viewed in3D viewing stations. 2D Images areobtained using the standard narrowbeam technique. | 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 qualifiedheath care professionals. | |
| Mode ofOperation | Same as predicate device #1 | Continuous operation withintermittent, stated permissibleloading | Same as predicate device #1 | |
| 3D technology | Same as predicate device #1 | CBCT Cone beamComputed Tomography | Same as predicate device #1 | |
| PerformanceSpecification | Same as predicate device #1 | 1) CBCT Computed tomography- Patient2) Panoramic3) Cephalometric(optional)- One shot type- Scan type | 1) CBCT Computed tomography- Patient- Dental Model Scan (Optional)2) Panoramic3) Cephalometric(optional)- One shot type- Scan type | |
| FunctionalOption | Same as predicate device #1 | 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 | Same as predicate device #1 | FXDD-0606CA | Same as predicate device #1 |
| CT | Jupi0606X | SiX 650HD-E | FXDD-1012CH | |
| PANO | Same as predicate device #1 | FXDD-0606CA | Same as predicate device #1 | |
| PANO | Jupi0606X | SiX 650HD-E | FXDD-1012CH | |
| Ceph (Scan) | Same as predicate device #1 | XID-C24DC | Same as predicate device #1 | |
| Ceph (One shot) | FXDD-1012CA | PaxScan 2530C | Same as predicate device #1 | |
| Ceph (One shot) | FXRD-1717VA | 1717SCC | Same as predicate device #1 | |
| Exposure switchType | Same as predicate device #1 | "Deadman" Button type | Same as predicate device #1 | |
| MainComponents | Same as predicate device #1 | Ceph Apparatus | Same as predicate device #1 | |
| MainComponents | Same as predicate device #1 | Vertical Carriage | Same as predicate device #1 | |
| MainComponents | Same as predicate device #1 | Rotator | Same as predicate device #1 | |
| Same as predicate device #1 | X-RAY Generator | Same as predicate device #1 | ||
| Same as predicate device #1 | X-ray tube | Same as predicate device #1 | ||
| Same as predicate device #1 | High Frequency Generator | Same as predicate device #1 | ||
| Same as predicate device #1 | Column | Same as predicate device #1 | ||
| Same as predicate device #1 | Touch monitor (panel) | Same as predicate device #1 | ||
| Detector- CTFXDD-0606CAJupi0606X- PANOFXDD-0606CAJupi0606X- CephXID-C24DC(Scan)FXDD-1012CA(One shot, StandardSize)FXRD-1717VA(One shot, Large Size) | Detector- CTFXDD-0606CASIX 650HD-E- PANOFXDD-0606CASIX 650HD-E- CephXID-C24DC(Scan)PaxScan 2530C(One shot, StandardSize)1717SCC(One shot, Large Size) | Detector- CTFXDD-0606CAFXDD-1012CH- PANOFXDD-0606CAFXDD-1012CHA- CephXID-C24DC(Scan)PaxScan 2530C(One shot, StandardSize)1717SCC(One shot, Large Size) | ||
| Same as predicate device #1 | Chinrest | Same as predicate device #1 | ||
| Same as predicate device #1 | Head rest | Same as predicate device #1 | ||
| Same as predicate device #1 | Automatic Collimator | Same as predicate device #1 | ||
| Same as predicate device #1 | Exposure switch | Same as predicate device #1 | ||
| Same as predicate device #1 | Emergency stop switch | Same as predicate device #1 | ||
| Same as predicate device #1 | Console PC set | Same as predicate device #1 | ||
| AutomaticCollimator | Same as predicate device #1 | CT examsPanoramic examsCephalometric exams | Same as predicate device #1 |
The following table provides the summary of the technological characteristics of RCT800 compared to the predicate device.
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| Display Type | Same as predicate device #1 | TFT LCD type(Normally black)*1280x800 pixel | Same as predicate device #1 | |
|---|---|---|---|---|
| Class | Same as predicate device #1 | Class I with type B applied partsaccording to IEC 60601-1 | Same as predicate device #1 | |
| Focal size | Same as predicate device #1 | 0.5 | Patient 0.5Model scan 0.04 (Optional) | |
| Field ofView(CT) | Same as predicate device #1 | Max.160x100 mm | FXDD-0606CA : Max.160x100 mmFXDD-1012CHA : Max. 200x200 mm | |
| X-ray Voltage(Patient) | Same as predicate device #2 | 60~90kVp | 60~100kVp | |
| X-ray Current(Patient) | 1~17mA | 4~17mA | Same as predicate device #1 | |
| Total Filtration | Same as predicate device #1 | Min. 2.8 mm Al equivalent | Same as predicate device #1 | |
| DetectorPixel size | CT | Same as predicate device #1 | FXDD-0606CA: 119μm | Same as predicate device #1 |
| Jupi0606X : 100μm | SiX 650HD-E : 150μm | FXDD-1012CHA: 124μm | ||
| PANO | Same as predicate device #1 | FXDD-0606CA: 119μm | Same as predicate device #1 | |
| Jupi0606X : 100μm | SiX 650HD-E : 150μm | FXDD-1012CHA: 124μm | ||
| Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 100μm | Same as predicate device #1 | |
| Ceph(One shot) | FXDD-1012CA : 124μm | PaxScan 2530C: 139μm | Same as predicate device #1 | |
| FXRD-1717VA : 140μm | 1717SCC: 127μm | Same as predicate device #1 | ||
| CT | Same as predicate device #1 | 1.44 | 1.44(Patient)1.91(Model Scan) | |
| PANO | Same as predicate device #1 | 1.31 | Same as predicate device #1 | |
| Magnification | Ceph (Scan) | Same as predicate device #1 | 1.11 | Same as predicate device #1 |
| Ceph(One shot) | Same as predicate device #1 | Standard Size : 1.12 | Same as predicate device #1 | |
| Same as predicate device #1 | Large Size : 1.13 | Same as predicate device #1 | ||
| Scan time | Same as predicate device #1 | CT : below 14sec | CT : below 20sec | |
| Same as predicate device #1 | Pano : below 14sec | Same as predicate device #1 | ||
| Same as predicate device #2 | Ceph[Scan type] : below 19sec | Ceph[Scan type] : below 20sec | ||
| Same as predicate device #1 | Ceph[One shot type]:below 2sec | Same as predicate device #1 | ||
| Format compatible | Same as predicate device #1 | DICOM 3.0 Format compatible | Same as predicate device #1 | |
| Image Viewing Software | Same as predicate device #1 | RayScan(Cleared under K182614) | RayScan(Cleared under K192737) | |
| Image acquisition | Same as predicate device #1 | Giga-Ethernet Network | Same as predicate device #1 | |
| Total Height | Same as predicate device #1 | Max 2,296mm | Same as predicate device #1 | |
| 1) Computed Tomography(CT) +Panoramic(PANO)=185kg(407.9lb) ±10% | 1) Computed Tomography(CT) +Panoramic(PANO)=189kg(416.6lb) ±10% | |||
| 2) Computed Tomography(CT) +Panoramic(PANO) + Ceph(Scan type)= 212.5kg (468.5lb) ± 10% | 2) Computed Tomography(CT) +Panoramic(PANO) + Ceph(Scan type)= 219kg (482.8lb) ± 10% | |||
| Weight | Same as predicate device #1 | 3) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Standardsize)= 211kg (465.2lb) ± 10% | 3) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Standardsize)= 217kg (478.4lb) ± 10% | |
| 4) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Large size)211kg (465.2lb) ± 10% | 4) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Large size)212kg (467.3lb) ± 10% | |||
| Type ofinstallation | Same as predicate device #1 | Wall or floor mount | Same as predicate device #1 | |
| Patient position | Same as predicate device #1 | Standing / Wheelchair | Same as predicate device #1 | |
| ApplicableStandards | Same as predicate device #1 | IEC 60601-1IEC 60601-1-3IEC 60601-2-63IEC 60601-1-2 | Same as predicate device #1 |
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The product is principally just the same as in the previous 510(k) #K182614 and K192737. The complete of differences of the subject device to the predicate device is as follows
- The minimum X-ray Current of the tube has been changed from 4mA to 1mA.
- Added new CT, Pano, Scan Ceph and One shot Ceph detector.
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11. Safety and Effectiveness Information
RCT700 system described in this 510(k) is similar to the predicate device in terms of indications for use, materials, safety characteristics, and X-ray source.
The following information further substantial equivalence between the subject device and predicate device.
The fundamental technological characteristics of the subject and predicate device are similar.
The imaging modes are similar; PANO, CEPH (Optional), CBCT All viewing software programs have been cleared with previous 510k submissions; RAYSCAN(K182614).
The sponsor tested the subject device in a laboratory and provided a non-clinical performance report. The same test protocol was used to test the performance of the subject and the predicate device for comparison. The sponsor certifies that adequate design and development controls (according to 21 CFR 820.30) were in place for manufacturing the subject device.
The differences are as follows.
- -The minimum X-ray Current of the tube has been changed from 4mA to 1mA.
- The irradiation time of One shot Ceph has been changed.
Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1: 2005/AMD1:2012(3.1 Edition), IEC 60601-1-3: 2008/AMD1:2013(Second Edition), IEC 60601-1-6:2010(Third Edition) and IEC 60601-2-63: 2012/AMD1:2017(First Edition) were performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2014(Edition 4.0).
The device software, named Rayscan, saves the patient and image data and offers an inquiry function, in addition, supports the image generate function intended to obtain images using the RCT700 equipment and various sensors for diagnosis. And that has been validated according to FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" to assure substantial equivalence.
RCT700 system described in this 510(k) is similar to the predicate device in terms of indications for use, materials, safety characteristics, and X-ray source.
The following information further substantial equivalence between the subject device and predicate device.
The fundamental technological characteristics of the subject and predicate device are similar.
The imaging modes are similar; PANO, CEPH (Optional), CBCT All viewing software programs have been cleared with previous 510k submissions; RAYSCAN(K182614).
The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.
As a result, we identified the level of concern associated with new device and provided documentation consistent with that level. Based on our risk analysis of software, the difference does not affect its safety and effectiveness.
Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s.
Bench testing is used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4 and IEC 61223-3-5.
All test results were satisfactory.
Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". Because the subject device used the
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same detector as the predicate device, there is no significant difference between the two devices as a result of non-clinical testing.
Clinical considerations were conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s.
Clinical images were provided these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
The features of RCT700 have been clinically tested and approved by two licensed practitioners/ clinicians.
The clinical imaging samples are collected from the all detector on propose device at the 2 offices where the predicate device is installed on clinical consideration report for the clinical test images. These images were gathered from the all detector installed with RCT700 on any protocols with random patient age, gender, and size. A licensed practitioner reviewed the sample clinical images and found them to be of acceptable quality for the intended use.
12. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. RAY Co., Ltd. concludes that the newly RCT700 is safe and effective and substantially equivalent to predicate device as described herein.
§ 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.