PHT-35LHS is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the maxillofacial areas for a dental treatment in adult and pediatric dentistry. The system also utilizes carpal images for orthodontic treatment. The device is operated and used by physicians, dentists and x-ray technicians.

Device Description

Green Smart (PHT-35LHS) is an advanced 5 in 1 digital X-ray imaging system that incorporates PANO, CEPH (Optional), CBCT, MODEL Scan and 3D PHOTO (Optional) imaging capabilities into a single system. Green Smart (PHT-35LHS), a digital radiographic imaging system, acquires and processes multi FOV diagnostic images for dentists. Specifically designed for dental radiography, Green Smart (PHT-35LHS) is a complete digital X-ray system equipped with imaging viewers, 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 head, neck, oral surgery, implant and orthodontic treatment. With Auto Pano function, It also reconstructs the 3D CT data and produces 2D panoramic images without an additional X-ray scan. Green Smart (PHT-35LHS) can also acquire 2D diagnostic image data in conventional panoramic and cephalometric imaging.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Green Smart, Model PHT-35LHS) seeking FDA clearance, demonstrating substantial equivalence to a predicate device. This document focuses on proving performance similarity rather than establishing new clinical effectiveness with human readers. Therefore, several of the requested sections (like MRMC studies, number of experts for ground truth, adjudication methods, and training set details for AI) are not applicable to this type of regulatory submission, as a human-in-the-loop AI model is not the subject of this 510(k). The "device" in question is an X-ray imaging system, not an AI algorithm.

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

Acceptance Criteria and Device Performance (as demonstrated for Substantial Equivalence)

The document implicitly defines acceptance criteria by comparing the performance parameters of the subject device (Green Smart) to its predicate device (PaX-i3D Smart). The goal is to show the new device is "equivalent or better" than the predicate in key imaging performance metrics.

Table of Acceptance Criteria and Reported Device Performance:

Performance Parameter	Acceptance Criteria (Implicit - Equivalent or Better than Predicate)	Reported Subject Device Performance	Notes
Xmaru1404CF-Plus (CBCT/PANO Detector)
Imaging Patterns	No aliasing throughout the same spatial frequency as predicate	No aliasing phenomenon	CMOS panel of new detector is "exactly same" as predicate; testing showed similar image patterns.
DQE	Similar or better than predicate	Performed similarly to predicate
MTF	Similar or better than predicate	Performed similarly to predicate
NPS	Similar or better than predicate	Performed similarly to predicate
Xmaru2602CF (Cephalometric Detector)
MTF	Better than predicate (Xmary2301CF)	Better performance parameters	New CMOS panel generates "better image quality."
DQE	Better than predicate (Xmary2301CF)	Better performance parameters
NPS	Better than predicate (Xmary2301CF)	Better performance parameters
General CT Image Quality (Iterative Reconstruction)
Contrast	Equivalent or better than predicate	Demonstrated equivalency/better	Measured with iterative reconstruction, indicating the overall imaging system performs well.
Noise	Equivalent or better than predicate	Demonstrated equivalency/better
CNR	Equivalent or better than predicate	Demonstrated equivalency/better
MTF	Equivalent or better than predicate	Demonstrated equivalency/better

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify a sample size in terms of patient images or subjects for the performance evaluations. Instead, it refers to "Non-Clinical Test results" and reports on the performance parameters of the device's components (detectors) and the overall system.
- The data provenance is a laboratory setting, as indicated by "The sponsor tested the subject device in a laboratory and provided a non-clinical performance report." The country of origin for the data is not explicitly stated, but the manufacturer (VATECH Co., Ltd.) is based in Korea. This is a part of a regulatory submission to the US FDA. The nature of the studies discussed (device performance parameters) makes them inherently prospective in the sense that the new device was built and then tested against a set of standards and against the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission focuses on the physical performance metrics of an X-ray imaging device (e.g., DQE, MTF, NPS, contrast, noise), not on diagnostic accuracy established by human readers interpreting images. Therefore, expert involvement for ground truth on image interpretation is not a component of this specific type of testing for substantial equivalence.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As the performance data pertains to technical specifications and physical image quality metrics rather than human interpretation accuracy, no adjudication method for diagnostic outcomes is described or required.
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. An MRMC comparative effectiveness study was not conducted as this is a 510(k) submission for a conventional X-ray imaging system, not an AI-based diagnostic tool. The document describes the system and its imaging capabilities, not an AI-assisted interpretation workflow.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device (X-ray system) with associated viewing software. There is no standalone external algorithm being proposed for independent performance evaluation in this submission. The "algorithm" here refers to the iterative reconstruction algorithm within the CT system itself, and its impact is evaluated through standard image quality metrics (Contrast, Noise, CNR, MTF).
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this type of technical performance testing is established through physical measurements and phantom studies using established standards and methodologies (e.g., IEC 61223-3-4, IEC 61223-3-5, 21 CFR 1020.33). These standards define how metrics like MTF, DQE, noise, and contrast are objectively measured using specialized test objects and equipment, not clinical data or expert interpretations.
The sample size for the training set:
- Not applicable. This is a hardware device clearance, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. As this is not an AI model, there is no training set or associated ground truth establishment for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 20, 2016

VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K162660

Trade/Device Name: Green Smart (Model PHT-35LHS) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: September 28, 2016 Received: September 29, 2016

Dear Mr. 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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162660

Device Name Green Smart (Model: PHT-35LHS)

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

1. 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

2. Date 510K Summary prepared: September 22, 2016

3. Administrative Information

Official Correspondent:	Dave Kim / Mtech Group8310 Buffalo Speedway, Houston, TX 77025Tel: +713-467-2607Fax: +713-583-8988Contact person: Mr. Dave Kim (davekim@mtech-inc.net)
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)

Device Information

Type of 510(k) Submission:	Special
Trade or Proprietary Name:	Green Smart (Model: PHT-35LHS)
Common or Usual Name:	Dental Computed Tomography X-ray System
Regulation Classification:	Computed tomography x-ray system (21 CFR 892.1750)
Product Code:	OAS
Class of Device:	Class II
Panel:	Radiology

Predicate Device Information

Manufacturer:	VATECH Co., Ltd.
Predicate device:	PaX-i3D Smart (PHT-30LFO) / K152106
Common or Usual Name:	X-Ray, Tomography, Computed, Dental
Regulation Classification:	Computed tomography x-ray system (21 CFR 892.1750)
Product Code:	OAS
Class of Device:	Class II
Panel:	Radiology

※ This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

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6. Device Description

Green Smart (PHT-35LHS) is an advanced 5 in 1 digital X-ray imaging system that incorporates PANO, CEPH (Optional), CBCT, MODEL Scan and 3D PHOTO (Optional) imaging capabilities into a single system.

Green Smart (PHT-35LHS), a digital radiographic imaging system, acquires and processes multi FOV diagnostic images for dentists. Specifically designed for dental radiography, Green Smart (PHT-35LHS) is a complete digital X-ray system equipped with imaging viewers, 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 head, neck, oral surgery, implant and orthodontic treatment. With Auto Pano function, lt also reconstructs the 3D CT data and produces 2D panoramic images without an additional X-ray scan.

Green Smart (PHT-35LHS) can also acquire 2D diagnostic image data in conventional panoramic and cephalometric imaging.

Key components of the device

1. Green Smart (Model: PHT-35LHS) digital x-ray equipment
1. SSXI detector: Xmaru1404CF-Plus, Xmaru2602CF

Item	Description
	CBCT/PANO	CEPHALOMETRIC
Model	Xmaru1404CF-Plus	Xmaru2602CF
Detector Type	CMOS photodiode array	CMOS photodiode array
Pixel Size	198µm @ 4X4 binning	200 µm @ 2X2 binning
Active Area	CBCT-36.4 x 135.8 mmPANO-5.9 x 135.8 mm	15.6 x 36.4 mm
Frame Rate	~308 fps (4x4 Binning)	~330 fps (2x2 Binning)
Analogue-Digital Conversion	14 bits	14 bits
Converter	Csl:Ti	Csl:Ti
Energy Range	50 ~ 120 kV	50 ~ 120 kV
Readout Type	Charge amplifier array	Charge amplifier array
Video Output	Optic	Optic

X-ray generator

Item			Description
High VoltageGenerator	Model		DG-07E22T2
	Rated output power		1.6 kW
	Type		Inverter
	Normal/Pulse	kV	60 ~ 99 kV
		mA	4 ~ 16 mA
	Cooling		Air (Optional fan cooling, ≥ 60 °C)
	Total filtration		Min. 2.5 mm Al
	Added filtration		1.5 mm Al (Fixed) / PANO and CEPH mode
			1.5 mm Al (Fixed) + 3.0 mm Al (Automatically added) / CBCTmode
X-ray Tube	Manufacturer		Toshiba
	Model		D-052SB (Stationary Anode type)
	Focal spot size		0.5 x 0.5 mm
	Target Angle		5 degree
	Inherent Filtration		At least 0.8 mm Al equivalent at 50 kV
	Anode Heat Content		35 kJ

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Item	Description
Duty Cycle	1:60 or more (Exposure time : Interval time)

4) PC system

Item	Description
Operating System	Windows 8 Professional 64-Bit OS
CPU	Intel Xeon E5-1607v3 3.1GHz 1866 4C or faster
RAM	16GB DDR4-2133 Registered RAM
HDD	1TB SATA 1st HDD
Graphics board	NVIDIA Geforce GTX970 D5 4GB or greater
Ethernet interface	Integrated Intel I218LM PCIeGbE
Serial Port (RS232)	HP Serial Port Adapter Kit
Power Supply	≥ 700 Watts (90% Efficiency)
Slots	2 PCI Express Gen3 x16 slot
	1 PCI Express Gen3 x8 Slot
	1 PCI Express Gen2 x4 Slot
	1 PCI Express Gen2 x1 Slot
	1 PCI Slot

5) Imaging software

Item	Description
2D Image Viewing Program	EasyDent (Cleared under K152106)EzDent-i (K161117)
3D Image Viewing Program	Ez3D Plus (Cleared under K152106)Ez3D-i (K161246)

7. Indication for use

Green Smart (Model: PHT-35LHS) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the maxillofacial areas for dental treatments in adult and pediatric dentistry. The system also utilizes for orthodontic treatment. The device is operated and used by physicians, dentists and x-ray technicians.

8. Comparison of Technological characteristics with the predicate device

	Subject Device	Predicate Device
Device Name	Green Smart(Model: PHT-35LHS)	PaX-i3D Smart(Model: PHT-30LFO)
Applicant Name	VATECH Co., Ltd.	VATECH Co., Ltd.
510(k) Number	N/A	K152106
Device Classification Name	X-Ray, Tomography, Computed, Dental	X-Ray, Tomography, Computed, Dental
Classification Product Code	OAS	OAS
Regulation Number	21 CFR 892.1750	21 CFR 892.1750
		Subject Device	Predicate Device
	Indications for Use	PHT-35LHS is a computed tomographyx-ray system intended to producepanoramic, cephalometric or cross-sectional images of the oral anatomyby computer reconstruction of x-rayimage data from the same axial planetaken at different angles. It providesdiagnostic details of the maxillofacialareas for dental treatments in adultand pediatric dentistry. The systemalso utilizes carpal images fororthodontic treatment. The device isoperated and used by physicians,dentists and x-ray technicians.	PHT-30LFO is a computed tomographyx-ray system intended to producepanoramic, cephalometric or cross-sectional images of the oral anatomyon a real time basis by computerreconstruction of x-ray image datafrom the same axial plane taken atdifferent angles. It provides diagnosticdetails of the anatomic structures byacquiring 360° rotational imagesequences of oral and maxillofacialarea for a precise treatment planningin adult and pediatric dentistry. Thedevice is operated and used byphysicians, dentists, and x-raytechnicians.
		Panoramic, Cephalometric and computed	Panoramic, Cephalometric and computed
	Performance Specification	tomography	tomography
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
	Scan Time	Max. 18 s	Max. 18 s
Slice Width		Min. 0.1 mm	Min. 0.1 mm
	Total Filtration	Min. 2.5 mm Al	Min. 2.8 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 Viewing Program		EasyDent (Identical to K152106)
		EzDent-i (K161117)	EasyDent
3D Image Viewing Program		Ez3D Plus (Identical to K152106)
		Ez3D-i (K161246)	Ez3D Plus
Anatomical Sites		Maxillofacial	Maxillofacial
	CT&PANO	Xmaru1404CF-Plus	Xmaru1404CF
			Xmaru2301CF
ImageReceptor	CEPH		1210SGA
		Xmaru2602CF	910SGA
			Xmaru2301CF-O
	Size of Imaging Volume	Max. 100 x 8.5 mm	Max. 100 x 8.5 mm
	CT&PANO		5 lp/mm -2x2 binning
Pixel		2.5 lp/mm -4x4 binning	2.5 lp/mm -4x4 binning
			5 lp/mm -Xmaru2301CF
Resolution	CEPH	2.5 lp/mm -2x2 binning	3.9 lp/mm -1210SGA
			3.9 lp/mm -910SGA
			5 lp/mm -Xmaru2301CF-O
			99 µm -2X2 binning
Pixel Size	CT&PANO	198 µm @ 4X4 binning	198 µm -4x4 binning
		Subject Device	Predicate Device
	CEPH	200 μm -2X2 binning	100 μm -Xmaru2301CF
			127 μm -1210SGA
			127 μm -910SGA
			100 μm -Xmaru2301CF-O

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9. Performance Data

Summary of Performance Testing

The Green Smart (Model: PHT-35LHS) digital X-ray 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 proposed device and predicate device:

The fundamental technological characteristics of the proposed and predicate device are similar. All viewing software programs have been cleared with previous 510k submissions; EasyDent (K152106), Ez 3D Plus (K152106), EzDent-i (K161117) and Ez3D-i (K161246).

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 subject device is equipped with new detectors, Xmaru1404CF-Plus and Xmaru2602CF.
। The subject device includes additional imaging modes; 3D Photo and Model Scan
-The subject device includes imaging viewer programs; EzDent-i (K161117) and Ez3D-i (K161246).

Green Smart (Model: PHT-35LHS), a digital radiographic imaging system is equipped with Xmaru1404CF-Plus and Xmaru2602CF. Xmaru1404CF-Plus is a new SSXI detector, which is used to capture an image in panoramic, CBCT and Model Scan. mode Xmaru2602CF, a new scan type detector, obtains a cephalometric image. In addition, the subject device is equipped with 3D photo mode and Model Scan mode. 3D photo mode does not require X-ray exposure. Model scan captures a dental model and reconstructs it in 3D.

Based on Non-Clinical Test results of Xmaru1404CF-Plus for the subject device, the CMOS panel of Xmaru1404CF-Plus is exactly same to that of the predicate device(Xmaru1404CF). Therefore, the testing image patterns of the new sensor show no aliasing phenomenon throughout the same spatial frequency as the predicate device. Moreover, the new sensor has performed similarly to the predicate device in terms of the DQE, MTF and NPS. All performance parameters for both detectors have shown similar results.

For the new detector Xmaru2602CF of the subject device, the Non-Clinical test results demonstrated better performance parameters compared to Xmary2301CF of the predicate device in terms of MTF, DQE and NPS. The new CMOS panel in Xmaru2602CF generates better image quality. All performance parameters for Xmaru2602CF detector have better results than Xmaru2301CF detector.

In addition, the acceptance test was performed according to the requirements of 21 CFR Part 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 iterative reconstruction

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algorithm for the new X-ray equipment. The results demonstrated that the general image quality of the subject device is equivalent or better than the predicate device.

Software Verification and Validation Testing

Software verification and validation activities 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.

Green Smart (Model: PHT-35LHS) provides the following imaging viewer programs;

2D Image viewing program: EasyDent (K152106), EzDent-i(K161117) -
-3D Image viewing program: Ez3D Plus (K152106), Ez3D-i(K161246)

Safety, EMC and Performance Data

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(Ed. 3, 2005), IEC 60601-1-3 (Ed. 2, 2008), IEC 60601-2-63 (Ed. 1, 2012) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

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.

Green Smart (Model: PHT-35LHS) conforms to the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.

Non-clinical consideration report according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" was provided.

Acceptance test and CT image evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were also performed.

All test results were satisfactory.

10. Conclusions

The proposed device and the predicate device have similar indications for use and demonstrated similar technical characteristics. As demonstrated in the performance test, the Xmaru1404CF-Plus and Xmaru2602CF performed similar or better in comparison with the predicate device in various performance parameters such as DQE, MTF and NNPS. In addition, the CT image evaluation of Contrast, Noise, CNR, and MTF further demonstrated the performance equivalency between the subject and predicate device. Quality assurance procedures are adhered to, and the specifications and functional requirements were met as the test results indicated.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, it is the sponsor's opinion that Green Smart (Model: PHT-35LHS) 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.