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.

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.

AI/ML Overview

The provided document details the 510(k) submission for the "Green X 12 (Model: PHT-75CHS)" dental X-ray imaging system. The submission aims to demonstrate substantial equivalence to a predicate device, the "Green X (Model: PHT-75CHS)" (K201627), and references another device, "Green Smart (Model: PHT-35LHS)" (K162660).

The primary changes in the subject device compared to the predicate device are:

New detector: Equipped with the Xmaru1404CF-PLUS detector (cleared with K162660).
New software functions: Auto Pano, Smart Focus, and Scout.

The document describes non-clinical performance evaluations rather than clinical studies with human readers.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific numerical thresholds and corresponding reported performance values for each criterion in an acceptance study. Instead, it states that the device's performance was compared to the predicate device and relevant standards.

However, based on the text, we can infer some criteria and the general findings:

Acceptance Criterion (Inferred)	Reported Device Performance
General Image Quality (CT)	Measured Contrast, Noise, CNR (Contrast-to-Noise Ratio), and MTF (Modulation Transfer Function) with FDK (back projection) and CS (iterative) reconstruction algorithms. Results demonstrated equivalent performance to the predicate device.
Dosimetric Performance (DAP)	In PANO mode, DAP (Dose Area Product) measurements were the same as the predicate device under identical FDD, exposure area, exposure time, tube voltage, and tube current. In CEPH mode, DAP measurements were the same as the predicate device under identical FDD, detector specifications, and exposure conditions.In CBCT mode (at common FOVs 80x80 / 80x50 / Endo 40x40 mm), the DAP of the subject device was lower than the predicate device.
Clinical Image Quality	Evaluation Report demonstrated that the general image quality of the subject device is equivalent to the predicate device in PANO/CBCT mode.
Software V&V	Software verification and validation were conducted according to FDA guidance. Considered "moderate" level of concern.
Cybersecurity	Applied in compliance with FDA guidance.
Safety, EMC, Performance	Electrical, mechanical, environmental safety, and performance testing conducted per standards (IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-2). All test results were satisfactory.
DICOM Conformance	Conforms to NEMA PS 3.1-3.18.
Added Software Functions	- Auto Pano: Already cleared in reference device (K162660).- Smart Focus: FOV 40x40 mm images were clinically evaluated by a US licensed dentist.- Image Quality (new software): Performed in compliance with IEC 61223-3-4 and IEC 61223-3-5. Both standard requirements were satisfied.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical performance and image quality evaluations rather than a test set of patient cases.

Sample Size for Test Set: Not applicable in the context of human patient data. The "test set" was described as physical measurements on the device itself and phantoms. No specific number of cases or images are mentioned for the "clinical evaluation" of Smart Focus or the image quality assessment of new functions beyond complying with IEC standards.
Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for patient data. The tests were laboratory-based and non-clinical. The "clinical evaluation" for Smart Focus was conducted by a "US licensed dentist," implying evaluation of generated images rather than a broad clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: For the "Smart Focus" mode, "a US licensed dentist" performed the clinical evaluation. This indicates at least one expert. For other image quality evaluations, the primary assessment relies on compliance with IEC standards and comparison to the predicate device, which would involve technical experts in radiology and medical imaging rather than medical specialists establishing "ground truth" on patient cases.
Qualifications of Experts: For Smart Focus, "a US licensed dentist" is specified. No specific years of experience are listed. For other evaluations, the experts are implied to be qualified in medical device testing, radiology physics, and engineering.

4. Adjudication Method for the Test Set

Not applicable. The evaluations described are primarily non-clinical measurements and comparisons against a predicate device or standards, rather than a diagnostic performance study requiring adjudication of expert interpretations of patient cases. The "clinical evaluation" of Smart Focus involved a single "US licensed dentist," suggesting no adjudication process was needed for this part.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to a predicate device, not on assessing human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The document primarily describes an imaging system, not an independent AI algorithm. However, the evaluation of "general image quality" (Contrast, Noise, CNR, MTF) for the CT reconstruction algorithms (FDK and CS) can be considered a standalone performance assessment of the image generation and processing aspects of the device, separate from human interpretation. The "new software functions" (Auto Pano, Smart Focus, Scout) are features of the device, and their performance was evaluated for image quality and clinical utility, effectively in a "standalone" manner in terms of the algorithm producing the image/feature.

7. The Type of Ground Truth Used

For the non-clinical image quality metrics (Contrast, Noise, CNR, MTF), the "ground truth" is based on physical measurements using phantoms and established metrology for X-ray imaging systems (e.g., as per IEC standards).
For the clinical evaluation of the Smart Focus mode, the "ground truth" is implied to be the expert opinion/assessment of a US licensed dentist regarding the quality and diagnostic utility of the 40x40 mm images.
For the new software functions' image quality evaluation, adherence to IEC 61223-3-4 and IEC 61223-3-5 standards serves as the ground truth/benchmark.

8. The Sample Size for the Training Set

Not applicable. This document describes the 510(k) submission for a medical imaging device (CT X-ray system) and its software functions, not a machine learning or AI algorithm that requires a separate training set for model development. The "Auto Pano" function, while a software feature, is not described as an AI algorithm that learns from data; it reconstructs 3D CBCT data into 2D panoramic images, a known image processing technique.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for a machine learning model is mentioned in the document.

Summary

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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)

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 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 GroupAddress: 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 (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

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.

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) isintended to produce panoramic,cephalometric or 3D digital x-ray images.It provides 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.	Green X (Model : PHT-75CHS) is intendedto produce panoramic, cephalometric or3D digital x-ray images. It providesdiagnostic 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.	Green Smart (Model: PHT-35LHS) is acomputed tomography x-ray systemintended to produce panoramic,cephalometric or cross-sectional imagesof the oral anatomy by computerreconstruction of x-ray image data fromthe same axial plane taken at differentangles. It provides diagnostic details ofthe maxillofacial areas for dentaltreatments in adult and pediatricdentistry. The system also utilizes carpalimages for orthodontic treatment. Thedevice is operated and used by physicians,dentists and x-ray technicians.
Performance Specification	Panoramic, Cephalometric and computedtomography	Panoramic, Cephalometric and computedtomography	Panoramic, Cephalometric and computedtomography
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)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-PLUS	Max. 120 x 85 mm	Xmaru1314CF	Max. 160 x 90 mm	Xmaru1404CF-PLUS	Max. 100 x 85 mm
PixelResolution	CT&PANO	Xmaru1404CF-PLUS	5 lp/mm -2x2binning (systemspec)2.5 lp/mm -4x4binning (systemspec)	Xmaru1314CF	5 lp/mm -2x2binning (systemspec)2.5 lp/mm -4x4binning (systemspec)	Xmaru1404CF-PLUS	5 lp/mm -2x2binning (detectorspec)2.5 lp/mm -4x4binning (systemspec)
	CEPH	5 lp/mm-Non binning (detector spec)2.5 lp/mm -2x2 binning (system spec)		5 lp/mm-Non binning (detector spec)2.5 lp/mm -2x2 binning (system spec)		5 lp/mm-Non binning (detector spec)2.5 lp/mm -2x2 binning (system spec)
Pixel Size	CT&PANO	Xmaru1404CF-PLUS	99 μm -2X2 binning(system spec)198 μm - 4X4binning (systemspec)	Xmaru1314CF	99 μm -2X2 binning(system spec)198 μm - 4X4binning (systemspec)	Xmaru1404CF-PLUS	99 μm -2X2 binning(detector spec)198 μm - 4X4binning (systemspec)
	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)		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 (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).
1. 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.

Regulation Number and Section

§ 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.