Grreen X 12 (Model: PHT-75CHS)
Device Facts
| Record ID | K231796 |
|---|---|
| Device Name | Grreen X 12 (Model: PHT-75CHS) |
| Applicant | VATECH Co., Ltd. |
| Product Code | OAS · Radiology |
| Decision Date | Jul 19, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Green X 12 (Model : PHT-75CHS) is intended to produce panoramic, cephalometric or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT, 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.
Device Story
Green X 12 is a 4-in-1 digital X-ray system (PANO, CEPH, CBCT, Model Scan) for dental radiography. It uses a CMOS digital X-ray detector to capture 2D/3D images of the head and neck. Operated by healthcare professionals in clinical settings, the system includes an X-ray generator and imaging viewers (EzDent-i, Ez3D-i). It processes multi-FOV diagnostic images to assist in oral surgery, implant planning, and orthodontic treatment. New software functions include Auto Pano (reconstructs 2D panoramic images from 3D CBCT data), Smart Focus (provides high-resolution 40x40 mm CBCT images), and Scout (previews/adjusts tooth positioning). Output is viewed by dentists to inform clinical decision-making, potentially improving diagnostic accuracy and treatment planning for dental and maxillofacial conditions.
Clinical Evidence
Bench testing only. Performance evaluated via non-clinical reports comparing subject and predicate devices. Image quality metrics (Contrast, Noise, CNR, MTF) measured using FDK and CS reconstruction algorithms per IEC 61223-3-5. Dosimetry (DAP) compared across PANO, CEPH, and CBCT modes. Smart Focus mode clinically evaluated by a US licensed dentist. All results demonstrated equivalence to the predicate.
Technological Characteristics
4-in-1 digital X-ray system (PANO, CEPH, CBCT, Model Scan). CMOS digital X-ray detector (Xmaru1404CF-PLUS). Tube voltage 60-99 kV, tube current 4-16 mA, focal spot 0.5x0.5 mm. Connectivity: DICOM 3.0 compatible. Software: EzDent-i (2D) and Ez3D-i (3D). Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-2, NEMA PS 3.1-3.18.
Indications for Use
Indicated for adult and pediatric patients requiring panoramic, cephalometric, or 3D digital X-ray imaging for dento-maxillofacial, ENT, sinus, and TMJ diagnostics, and carpal imaging for orthodontic treatment.
Regulatory Classification
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.
Predicate Devices
- Green X (Model : PHT-75CHS) (K201627)
Reference Devices
Submission Summary (Full Text)
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July 19, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name in a sans-serif font. The full name is "U.S. Food & Drug Administration".
Vatech Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St. Ste 610 HOUSTON, TX 77054
Re: K231796
Trade/Device Name: Grreen X 12 (Model: PHT-75CHS) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: June 12, 2023 Received: June 20, 2023
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 (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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radialogical 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) K231796
Device Name Green X 12 (Model : PHT-75CHS)
#### Indications for Use (Describe)
Green X 12 (Model : PHT-75CHS) is intended to produce panoramic, cephalometric or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT, sinus 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) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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# 510(k) Summary K231796
# 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: July 12, 2023
#### 3. Administrative Information
| Official Correspondent: | Dave Kim / Mtech Group<br>Address: 7505 Fannin Street, Suite 610, Houston, TX 77054<br>Tel: +713-467-2607<br>Contact person: Mr. Dave Kim (davekim@mtechgroupllc.com) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | VATECH Co., Ltd.<br>Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea<br>Tel: +82-31-379-9492<br>Fax: +82-31-379-9400<br>Contact 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 (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 |
## 5. Predicate Device Information
| Manufacturer: | VATECH Co., Ltd. |
|----------------------------|---------------------------------------------------|
| Trade or Proprietary Name: | Green X (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: | K201627 |
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## 6. Device Description
Green X 12 (Model : PHT-75CHS) 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 (Model : PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography. Green X 12 (Model : PHT-75CHS) 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 (Model : PHT-75CHS) 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 to the predicate device (PHT-75CHS (K201627)). The difference from the predicate device is that the maximum FOV provided to the user is different by equipping the new CBCT/PANO detector. Also, New software functions (Auto Pano, Smart Focus, Scout) have been added.
# 7. Indication for use
Green X 12 (Model : PHT-75CHS) is intended to produce panoramic, cephalometric or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT, 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.
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#### VATECH Co., Ltd.
## Premarket Notification 510(k)=
# 8. Substantial Equivalence Chart
| | Subject Device | Predicate Device | Reference Device |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Green X 12 (Model : PHT-75CHS) | Green X (Model : PHT-75CHS) | Green Smart (Model : PHT-35LHS) |
| Applicant Name | VATECH Co., Ltd. | VATECH Co., Ltd. | VATECH Co., Ltd. |
| 510(k) Number | K231796 | K201627 | K162660 |
| Device Classification Name | X-Ray, Tomography, Computed, Dental | X-Ray, Tomography, Computed, Dental | X-Ray, Tomography, Computed, Dental |
| Classification Product Code | OAS | OAS | OAS |
| Regulation Number | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 872.1800 |
| Indications for Use | Green X 12 (Model : PHT-75CHS) is<br>intended to produce panoramic,<br>cephalometric or 3D digital x-ray images.<br>It provides diagnostic details of the dento-<br>maxillofacial, ENT, sinus and TMJ for adult<br>and pediatric patients. The system also<br>utilizes carpal images for orthodontic<br>treatment The device is to be operated by<br>healthcare professionals. | Green X (Model : PHT-75CHS) is intended<br>to produce panoramic, cephalometric or<br>3D digital x-ray images. It provides<br>diagnostic details of the dento-<br>maxillofacial, ENT, sinus and TMJ for adult<br>and pediatric patients. The system also<br>utilizes carpal images for orthodontic<br>treatment The device is to be operated by<br>healthcare professionals. | Green Smart (Model: PHT-35LHS) is a<br>computed tomography x-ray system<br>intended to produce panoramic,<br>cephalometric or cross-sectional images<br>of the oral anatomy by computer<br>reconstruction of x-ray image data from<br>the same axial plane taken at different<br>angles. It provides diagnostic details of<br>the maxillofacial areas for dental<br>treatments in adult and pediatric<br>dentistry. The system also utilizes carpal<br>images for orthodontic treatment. The<br>device is operated and used by physicians,<br>dentists and x-ray technicians. |
| Performance Specification | Panoramic, Cephalometric and computed<br>tomography | Panoramic, Cephalometric and computed<br>tomography | Panoramic, Cephalometric and computed<br>tomography |
| Input Voltage | AC 100 - 240 V | AC 100 - 240 V | AC 100 - 240 V |
| X-Ray source | D-052SB | D-052SB | D-052SB |
| Tube Voltage | 60 - 99 kV | 60 - 99 kV | 60 - 99 kV |
| Tube Current | 4 - 16 mA | 4 - 16 mA | 4 - 16 mA |
| Focal Spot Size | 0.5 x 0.5 mm | 0.5 x 0.5 mm | 0.5 x 0.5 mm |
| Exposure Time | Max. 18.0 s | Max. 18.0 s | Max. 18.0 s |
| Slice Width | Min. 0.1 mm | Min. 0.1 mm | Min. 0.1 mm |
| Total Filtration | Min. 2.5 mm Al | Min. 2.5 mm Al | Min. 2.5 mm Al |
| Mechanical | Compact design | Compact design | Compact design |
| Electrical | LDCP logic circuit | LDCP logic circuit | LDCP logic circuit |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| 2D Image Viewing Program | EzDent-i (K223820) | EzDent-i (K223820) | EasyDent(Cleared under K162660)<br>EzDent-i (K223820) |
| 3D Image Viewing Program | Ez3D-i (K222069) | Ez3D-i (K222069) | Ez3D Plus (Cleared under K162660) |
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VATECH Co., Ltd.
Premarket Notification 510(k)=
| | | Premarket Notification 510(k) | | | | | |
|------------------------|---------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| | | Subject Device | | Predicate Device | | Reference Device | |
| | | | | | | Ez3D-i (K222069) | |
| Anatomical Sites | | Maxillofacial | | Maxillofacial | | Maxillofacial | |
| Image | CT&PANO | Xmaru1404CF-PLUS | | Xmaru1314CF | | Xmaru1404CF-PLUS | |
| Receptor | CEPH | Xmaru2602CF | | Xmaru2602CF | | Xmaru2602CF | |
| Size of Imaging Volume | | Xmaru1404CF-<br>PLUS | Max. 120 x 85 mm | Xmaru1314CF | Max. 160 x 90 mm | Xmaru1404CF-<br>PLUS | Max. 100 x 85 mm |
| Pixel<br>Resolution | CT&PANO | Xmaru1404CF-<br>PLUS | 5 lp/mm -2x2<br>binning (system<br>spec)<br>2.5 lp/mm -4x4<br>binning (system<br>spec) | Xmaru1314CF | 5 lp/mm -2x2<br>binning (system<br>spec)<br>2.5 lp/mm -4x4<br>binning (system<br>spec) | Xmaru1404CF-<br>PLUS | 5 lp/mm -2x2<br>binning (detector<br>spec)<br>2.5 lp/mm -4x4<br>binning (system<br>spec) |
| | CEPH | 5 lp/mm-Non binning (detector spec)<br>2.5 lp/mm -2x2 binning (system spec) | | 5 lp/mm-Non binning (detector spec)<br>2.5 lp/mm -2x2 binning (system spec) | | 5 lp/mm-Non binning (detector spec)<br>2.5 lp/mm -2x2 binning (system spec) | |
| Pixel Size | CT&PANO | Xmaru1404CF-<br>PLUS | 99 μm -2X2 binning<br>(system spec)<br>198 μm - 4X4<br>binning (system<br>spec) | Xmaru1314CF | 99 μm -2X2 binning<br>(system spec)<br>198 μm - 4X4<br>binning (system<br>spec) | Xmaru1404CF-<br>PLUS | 99 μm -2X2 binning<br>(detector spec)<br>198 μm - 4X4<br>binning (system<br>spec) |
| | CEPH | 100 μm- Non binning (detector spec)<br>200 μm -2X2 binning (system spec) | | 100 μm- Non binning (detector spec)<br>200 μm -2X2 binning (system spec) | | 100 μm- Non binning (detector spec)<br>200 μm -2X2 binning (system spec) | |
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#### 9. Performance Data
## - Summary of Performance Testing
The Green X 12 (Model : PHT-75CHS) 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 is equipped with a new detector, Xmaru1404CF-PLUS.
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 similar; PANO, CEPH (Optional), CBCT and 3D MODEL Scan. All viewing software programs have been cleared with previous 510k submissions; EzDent-i (K223820) and Ez3D-i (K222069). 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 both devices, the differences are as follows.
- 1) The subject device is equipped with the Xmaru1404CF-PLUS detector which has been cleared with previous 510k submissions, PHT-35LHS (K162660).
- 2) The subject device includes additional Software functions; Auto Pano, Smart Focus, Scout
- a. The Auto Pano function reconstructs 3D CBCT data to create 2D panoramic images without separate Xray scans. Auto Pano function was previously cleared by the reference device, PHT-35LHS (K162660).
- b. Smart focus function provides a high-resolution CBCT image in the FOV 40x40 mm that the user can designate from 1 to 3 images in the console SW after acquiring a projection of the entire tooth. Full arch CT (FOV 120x85 mm) and Auto Pano images are additionally provided as user options.
- Scout is a function provided in FOV 80x50 mm and Endo(40x40 mm) mode, which allows the user to ﻥ preview and adjust the position of teeth before taking a Small FOV image.
The acceptance test was performed according to the requirements of 21 CFR Part 1020.30. 1020.33 and IEC 61223-3-5, Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment. 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), exposure area, DAP measurement in the PANO mode of each device under the same X-ray exposure time, tube voltage, tube current) was the same. The CEPH mode for the subject device and the predicate device also has the same FDD(Focal Spot to Detector Distance), the same detector specifications, the same DAP measurement under the same X-ray exposure conditions (exposure time, tube voltage, tube current).
In CBCT mode, the direct comparison of the dosimetry performance for each mode available in the subject and predicate device is different exposure conditions such as the exposure area and exposure conditions(exposure time, tube current). Considering these differences, DAP was compared at the same FOV of 80x80 / 80x50 / Endo (40x40) mm supported by both devices. As a result of the comparison, the DAP of the Subjective device was lower than the Predicate device.
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Moreover, the Clinical consideration and Image Quality Evaluation Report further demonstrated that the general image quality of the subject device is equivalent to the predicate device in PANO/CBCT mode.
## - Software Verification and Validation Testing
Software verification and validation were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." 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.
Cyber security was applied in compliance with FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Green X 12 (Model: PHT-75CHS) provides the following imaging viewer programs;
- -2D Image viewing program: EzDent-i (K223820)
- । 3D Image viewing program: Ez3D-i (K222069)
# - Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:2005+AMD1:2012(Edition 3.1), IEC 60601-1-3:2008+AMD1:2013 (Edition 2.1), 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 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 and cleared from previous 510k submissions(K162660) 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.
We also reviewed the recommendations of FDA Pediatric Information for X-ray Imaging Device Premarket Notifications" for safe imaging in the pediatric populations and included them in Instructions for use and labeling.
All test results were satisfactory.
## 10. Conclusions
Safety and effectiveness of New-detector application and additional software functions 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 and the predicate device have same indications for use and demonstrated same technical characteristics. The new applied detector "Xmaru1404CF-PLUS' was previously cleared by the reference device, PHT-35LHS (K162660). Among the added software functions; Auto Pano, Smart Focus and Scout modes, the Auto Pano function has already been incorporated in previous devices which obtained premarket clearance by FDA and widely used in the market. To demonstrate the performance of the Smart focus mode function, the FOV 40x40 mm image provided in Smart Focus mode was clinically evaluated by a US licensed dentist. And lmage quality evaluation of new software functions was performed in compliance with IEC 61223-3-4 and IEC 61223-3-5. Both standard requirements were satisfied.
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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 (Model: PHT-75CHS) is substantially equivalent to the predicate device as described herein.
