(144 days)
Green X 12 SE (Model : PHT-40CHS) is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus, and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.
Green X 12 SE (Model : PHT-40CHS) is an advanced 4-in-1 digital X-ray imaging system that incorporates PANO, CEPH(optional), CBCT and MODEL Scan imaging capabilities into a single system. Green X 12 SE (Model : PHT-40CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography. Green X 12 SE (Model : PHT-40CHS) is a complete digital X-ray system equipped with imaging viewers, an X-ray generator and a dedicated SSXI detector. The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT detector is used to capture 3D radiographic images of the head, neck, oral surgery, implant and orthodontic treatment. Green X 12 SE (Model : PHT-40CHS) can also acquire 2D diagnostic image data in conventional PANO and CEPH modes.
The provided document does not contain information regarding a study that proves the device meets specific acceptance criteria in the context of AI performance, clinical trials, or comparative effectiveness studies with human readers. The document describes a Computed Tomography X-Ray System named Green X 12 SE (PHT-40CHS) and its substantial equivalence to a predicate device (Green X 12 (PHT-75CHS)).
The performance data section primarily focuses on:
- Substantial Equivalence: Demonstrating that the new device is equivalent to the predicate device despite minor changes in detector technology and some feature deletions.
- Technical Performance Testing: Verification against international standards (IEC 61223-3-5) for general image quality indicators like Contrast, Noise, CNR, and MTF, and dosimetric performance (DAP).
- Safety and EMC: Compliance with relevant IEC standards for electrical, mechanical, environmental safety, and electromagnetic compatibility.
- Software Verification and Validation: Adherence to FDA guidance for device software functions.
Therefore, many of the requested categories for AI-related studies and acceptance criteria are not applicable based on the provided text.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a table format for AI performance. Instead, it refers to equivalence to a predicate device and compliance with international performance standards for Computed Tomography X-ray systems.
| Criterion Type (Inferred from Text) | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Image Quality | Performed equivalently to the predicate device according to IEC 61223-3-5. | Contrast, Noise, CNR, and MTF were measured and demonstrated that the subject device performed equivalently to the predicate device in general image quality. |
| Dosimetric Performance | DAP measurements should be the same as the predicate device under identical exposure conditions. | DAP measurements in PANO, CEPH, and CBCT modes were the same as the predicate device under the same X-ray exposure conditions (exposure time, tube voltage, tube current). |
| Software Functionality | Compliance with FDA guidance for device software functions. Software criticality assessed as "basic documentation." | Software verification and validation were conducted and documented as recommended by FDA guidance. The Green X 12 SE provides EzDent-i (K241114) for 2D viewing and Ez3D-i (K231757) for 3D viewing, both previously cleared. |
| Safety and EMC | Compliance with IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-3:2008+AMD1:2013+AMD2:2021, IEC 60601-2-63:2012+AMD1:2017+AMD2:2021, and IEC 60601-1-2:2014+AMD1:2020. | Electrical, mechanical, environmental safety, and EMC testing were performed per specified IEC standards. All test results were satisfactory. The device also conforms to NEMA PS 3.1-3.18 (DICOM Set). |
| Manufacturing Standards | Conformance with 21 CFR Part 1020.30, 1020.31, 1020.33, and 21 CFR 820.30. | The manufacturing facility is in conformance with relevant EPRC standards. Adequate design and development controls (according to 21 CFR 820.30) were in place. |
2. Sample size used for the test set and the data provenance: Not applicable. The document discusses bench testing and comparison to a predicate device, not a test set of patient cases for AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This information is relevant for AI (CAD) performance studies, which are not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: No MRMC study was described. The device is an X-ray imaging system, not an AI-assisted diagnostic tool in the sense of a CADe/CADx system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI performance. For the technical performance aspects, the "ground truth" would be established by the specifications and measurements according to IEC standards.
8. The sample size for the training set: Not applicable. This device is an imaging system, not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.
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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, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
February 21, 2025
VATECH Co., Ltd % Dave Kim RA Consultant Mtech Group LLC 7505 Fannin St. Suite 610 HOUSTON, TX 77054
Re: K243088
Trade/Device Name: Green X 12 SE (PHT-40CHS) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: January 23, 2025 Received: January 23, 2025
Dear Dave Kim:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 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-regulatory
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assistance/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
Submission Number (if known)
Device Name
Green X 12 SE (PHT-40CHS)
Indications for Use (Describe)
Green X 12 SE (Model : PHT-40CHS) is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus, and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare 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 K243088
1. Special 510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
2. Date 510K Summary prepared: February 20, 2025
3. Administrative Information
| Official Correspondent: | Dave Kim / Mtech Group LLCAddress: 7505 Fannin Street, Suite 610, Houston, TX 77054Tel: +713-467-2607Contact person: Mr. Dave Kim (davekim@mtechgroupllc.com) |
|---|---|
| 510(k) Submitter: | VATECH Co., Ltd.Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, KoreaTel: +82-31-379-9492Fax: +82-31-379-9400Contact person: Daniel Kim / Manager (daniel.kim@vatech.co.kr) |
4. Device Information
| Type of 510(k) Submission: | Special |
|---|---|
| Trade or Proprietary Name: | Green X 12 SE (PHT-40CHS) |
| Common or Usual Name: | System, X-ray, Computed tomography, Dental |
| Regulation Classification: | Computed tomography x-ray system(21 CFR 892.1750) |
| Product Code: | OAS |
| Class of Device: | Class II |
| Panel: | Radiology |
5. Predicate Device Information
| Manufacturer: | VATECH Co., Ltd. |
|---|---|
| Trade or Proprietary Name: | Green X 12 (Model : PHT-75CHS) |
| Common or Usual Name: | System, X-ray, Computed tomography, Dental |
| Regulation Classification: | Computed tomography x-ray system(21 CFR 892.1750 |
| Product Code: | OAS |
| Class of Device: | Class II |
| Panel: | Radiology |
| 510(k) Number: | K231796 |
Copyright © 2021 VATECH Networks | All Rights Reserved.
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6. Device Description
Green X 12 SE (Model : PHT-40CHS) is an advanced 4-in-1 digital X-ray imaging system that incorporates PANO, CEPH(optional), CBCT and MODEL Scan imaging capabilities into a single system. Green X 12 SE (Model : PHT-40CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography. Green X 12 SE (Model : PHT-40CHS) is a complete digital X-ray system equipped with imaging viewers, an X-ray generator and a dedicated SSXI detector.
The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT detector is used to capture 3D radiographic images of the head, neck, oral surgery, implant and orthodontic treatment.
Green X 12 SE (Model : PHT-40CHS) can also acquire 2D diagnostic image data in conventional PANO and CEPH modes.
The materials, safety characteristics, X-ray source, indications for use and image reconstruction/MAR(Metal Artifact Reduction) algorithm of the subject device are same as the predicate device (PHT-75CHS (K231796)). The difference from the predicate device is that Green X 12 SE (Model : PHT-40CHS) is equipped with a new ethernet type detector and some features are deleted (Double Scan).
7. Indication for use
Green X 12 SE (Model : PHT-40CHS) is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus, and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.
Copyright © 2021 VATECH Networks | All Rights Reserved
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8. Comparison of Technological characteristics with the predicate device
| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Device Name | Green X 12 SE (Model : PHT-40CHS) | Green X 12 (Model : PHT-75CHS) | |||
| Applicant Name | VATECH Co., Ltd. | VATECH Co., Ltd. | |||
| 510(k) Number | K231796 | ||||
| Device ClassificationName | X-Ray, Tomography, Computed, Dental | X-Ray, Tomography, Computed, Dental | |||
| Classification ProductCode | OAS | OAS | |||
| Regulation Number | 21 CFR 892.1750 | 21 CFR 892.1750 | |||
| Indications for Use | Green X 12 SE (Model : PHT-40CHS) isintended to produce panoramic,cephalometric, or 3D digital x-ray images.It provides diagnostic details of the dento-maxillofacial, sinus, and TMJ for adult andpediatric patients. The system also utilizescarpal images for orthodontic treatment.The device is to be operated by healthcareprofessionals. | Green X 12 (Model : PHT-75CHS) isintended to produce panoramic,cephalometric or 3D digital x-ray images. Itprovides diagnostic details of the dento-maxillofacial, ENT, sinus and TMJ for adultand pediatric patients. The system alsoutilizes carpal images for orthodontictreatment The device is to be operated byhealthcare professionals. | |||
| PerformanceSpecification | Panoramic, Cephalometric and computedtomography | Panoramic, Cephalometric and computedtomography | |||
| Input Voltage | AC 100 - 240 V | AC 100 - 240 V | |||
| X-ray source | D-052SB | D-052SB | |||
| Tube Voltage | 60 - 99 kV | 60 - 99 kV | |||
| Tube Current | 4 - 16 mA | 4 - 16 mA | |||
| Focal Spot Size | 0.5 x 0.5 mm | 0.5 x 0.5 mm | |||
| Exposure Time | Max. 16.9 s | Max. 18.0 s | |||
| Slice Width | Min. 0.1 mm | Min. 0.1 mm | |||
| Total Filtration | Min. 2.5 mm Al | Min. 2.5 mm Al | |||
| Mechanical | Compact design | Compact design | |||
| Electrical | LDCP logic circuit | LDCP logic circuit | |||
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | |||
| 2D Image ViewingProgram | EzDent-i (K241114) | EzDent-i (K241114) | |||
| 3D Image ViewingProgram | Ez3D-i (K231757) | Ez3D-i (K231757) | |||
| Anatomical Sites | Maxillofacial | Maxillofacial | |||
| X-ray | CT&PANO | Xmaru1404CF-PLUS Eth | Xmaru1404CF-PLUS | ||
| detector | CEPH | Xmaru2602CF Eth | Xmaru2602CF | ||
| Size of Imaging Volume | Xmaru1404CF-PLUSEth | Max. 120 x 85 mm | Xmaru1404CF-PLUS | Max. 120 x 85 mm | |
| Pixel Size | CT&PANO | 99 μm -2X2 binning (system spec)198 μm - 4X4 binning (system spec) | 99 μm -2X2 binning (system spec)198 μm - 4X4 binning (system spec) | ||
| CEPH | 100 μm- Non binning (detector spec)200 μm -2X2 binning (system spec) | 100 μm- Non binning (detector spec)200 μm -2X2 binning (system spec) |
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9. Performance Data
-Summary of Performance Testing
The Green X 12 SE (Model : PHT-40CHS) digital X-ray system described in this 510(k) is identical to the predicate device in terms of indications for use, materials, safety characteristics, X-ray source and image reconstruction /MAR(Metal Artifact Reduction) process algorithm. The subject device applied the 'Eth' series. which changed the optical communication method of the X-ray detector 'Xmaru1404CF-Plus (Pano/CT) & Xmaru2606CF (Ceph)' used in the predicate device to the Ethernet communication method. In addition, the SW function was simplified compared to the preceding device.
The following information further substantial equivalence between the subject device and the predicate device : The fundamental technological characteristics of the subject and predicate device are identical. The imaging modes are also Identical; PANO, CEPH (Optional), CBCT and MODEL. All viewing software programs have been cleared with previous 510k submissions; EzDent-i (K241114) and Ez3D-i (K231757). 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.
For the two devices, the differences are as follows.
-
- The subject device is equipped with the Xmaru1404CF-PLUS Eth and Xmaru2602CF Eth detector where predicate device is equipped with Xmaru1404CF-Plus and Xmaru2602CF detector. 'Eth' means a model with an Ethernet communication port.
-
- The subject device has Double Scan features deleted compared to the predicate device. For this, the chinrest up/down motor for using the double scan mode has been removed. (D.C. stepping motor)
-
- The capacitive touch keypad of the Control Panel Part (handle frame) has been changed to a membrane switch.
For the IQ performance testing, the acceptance test was performed according to the requirements of 21 CFR Part 1020.30. 1020.33 and IEC 61223-3-5, international performance standard for computed tomography X-ray system. Contrast, Noise, CNR, and MTF, the representative indicators for CT image quality were measured with FDK(back projection) and CS(iterative) reconstruction algorithm for the new X-ray equipment. The results demonstrated that the subject device performed equivalently to the predicate device in the general image quality.
In addition, the dosimetric performance of the subject device and the predicate device was compared in terms of DAP. With the identical FDD (Focal Spot to Detector Distance) and exposure area, DAP measurement in the PANO, CEPH, and CBCT mode of each device under the same X-ray exposure conditions (exposure time, tube voltage, tube current) was the same. The subject and predicate device in the Clinical Consideration Report and Image Quality Evaluation Report (Model: PHT-40CHS) were considered as well to ensure the validity of the dose evaluation.
Moreover, the Non-clinical considerations and Image Quality Evaluation Report further demonstrated that the general image quality of the subject device is equivalent to the predicate device.
Software/Firmware Verification and Validation Testing
Software verification and validation were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions | FDA." The software for this device was considered was considered as a basic documentation, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.
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Green X 12 SE (Model: PHT-40CHS) provides the following imaging viewer programs;
Safety and EMC and Performance Data -
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:2005+AMD1:2012+AMD2:2020(Edition 3.2), IEC 60601-1-3:2008+AMD1:2013+AMD2:2021 (Edition 2.2), IEC 60601-2-63:2012+AMD1:2017+AMD2:2021 (Edition 1.2) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2014+AMD1:2020 (Edition 4.1). The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31, and 33 and the records are available for review. The Green X 12 SE conforms to the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.
Non-clinical consideration report was provided in accordance with the FDA guidelines "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, Performance Testing - Bench" were performed. Image Quality evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were also performed.
Applied FDA Guidance
- "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket . Submission"
- . "Content of Premarket Submissions for Device Software Functions | FDA"
- . "Off-the-Shelf Software Use in Medical Devices"
- . "Pediatric Information for X-ray Imaging Device Premarket Notifications"
- . "Electromagnetic Compatibility (EMC) of Medical Devices"
All test results were satisfactory.
10. Conclusions
Safety and effectiveness of new-detector application have been clarified through each verification. Subject device has been evaluated according to the international standard and U.S. code and proved to be equivalent to the predicate device.
The subject device is designed as a lower-end product line that provides imaging performance equivalent to that of the predicate device. In this regard, some hardware has been removed/changed (d.c. stepping motor, membrane switch), and the data transmission method has been changed from optical communication to Ethernet communication. The subject device and the predicate device have same indications for use and demonstrated same technical characteristics. It was confirmed that both standard requirements were met through evaluation according to IEC 61223-3-4 and IEC 61223-3-5.
Quality assurance procedures are adhered to, and the specifications and functional requirements have been verified.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, VATECH Co., Ltd. concludes that Green X 12 SE (Model: PHT-40CHS) is 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.