Green X 18 (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 Description

Green X 18 (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 18 (Model : PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography. Green X 18 (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. 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 it is equipped with a new CBCT/PANO detector to provide users with a larger CBCT FOV.

AI/ML Overview

The medical device in question is the Green X 18 (Model: PHT-75CHS), a digital X-ray imaging system for panoramic, cephalometric, and 3D dental imaging. The study described focuses on demonstrating substantial equivalence to a predicate device, the Green X (Model: PHT-75CHS, K201627), particularly concerning a new detector, Xmaru1524CF Master Plus OP.

Based on the provided text, the acceptance criteria and study information can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating equivalence to the predicate device rather than setting specific numeric acceptance criteria for unique features or diagnostic accuracy. Instead, the acceptance is based on the new detector performing "equivalently or better" than the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance (Subject Device vs. Predicate Device)
Technological Characteristics	The fundamental technological characteristics of the subject and predicate device are identical. Similar imaging modes (PANO, CEPH (Optional), CBCT, and 3D MODEL Scan). The materials, safety characteristics, X-ray source, indications for use, and image reconstruction/MAR (Metal Artifact Reduction) algorithm are the same as the predicate device. The difference is the new CBCT/PANO detector for a larger CBCT FOV.
Pixel Resolution (New Detector vs. Predicate Detector)	New Detector (Xmaru1524CF Master Plus OP): 5 lp/mm (2x2 binning), 2.5 lp/mm (4x4 binning) for CT&PANO.
	Predicate Detector (Xmaru1314CF): 5 lp/mm (2x2 binning), 2.5 lp/mm (4x4 binning). Test patterns of the new sensor images show the test subjects without aliasing throughout the same spatial frequency as the predicate device.
DQE Performance (New Detector vs. Predicate Detector)	New Detector (Xmaru1524CF Master Plus OP): Similarly or better overall DQE performance. At a low spatial frequency (~0.5 lp/mm), DQE of 41% (4x4 binning).
	Predicate Detector (Xmaru1314CF): DQE of 36% (4x4 binning) at ~0.5 lp/mm.
MTF and NPS Performance (New Detector vs. Predicate Detector)	The new sensor also exhibits similar performances in terms of MTF and NPS.
Image Quality (Contrast, Noise, CNR, MTF in CT mode)	The subject device performed equivalently or better than the predicate device in the general image quality, measured with FDK (back projection) and CS (iterative) reconstruction algorithm.
Dosimetric Performance (DAP)	PANO mode: DAP measurement was the same under identical FDD, exposure area, X-ray exposure time, tube voltage, and tube current.
	CEPH mode: DAP measurement was the same under identical FDD, detector specifications, X-ray exposure conditions (exposure time, tube voltage, tube current).
	CBCT mode: DAP measurements compared at different FOV sizes (12x9/8x8/8x5/5x5 cm) were equivalent under identical FDD and exposure conditions.
General Clinical Image Quality (PANO/CBCT mode)	The Clinical consideration and Image Quality Evaluation Report further demonstrated that the general image quality of the subject device is equivalent or better than the predicate device.
Compliance with Standards (Non-Clinical)	The acceptance test was performed according to the requirements of 21 CFR Part 1020.30, 1020.33 and IEC 61223-3-5. The device passed these tests. 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. Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, Performance Testing – Bench" were performed. Acceptance test and Image evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were also performed. All test results were satisfactory.
Software Verification and Validation	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 was considered a "moderate" level of concern. The viewing programs EzDent-i (K202116) and Ez3D-i (K200178) were previously cleared.
Safety, EMC, and Performance Standards (Electrical, Mechanical, Environmental)	Electrical, mechanical, environmental safety and performance testing according to 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 (Edition 1.1) were performed. EMC testing was conducted in accordance with IEC 60601-1-2:2014 (Edition 4). Manufacturing facility conforms with relevant EPRC standards (21 CFR 1020.30, 31, and 33). Conforms to NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set. All test results were satisfactory.

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

Sample Size: Not explicitly stated as a number of patient cases or images. The performance testing was conducted in a laboratory setting using test protocols and phantoms, not a clinical test set of patient images.
Data Provenance: The testing was "non-clinical" and "in a laboratory." It compared the performance of the new detector and the subject device against the predicate device. This implies retrospective comparison against previously established performance data for the predicate, and possibly prospective bench testing on the new device itself. The data is likely from the manufacturer's internal testing facilities (presumably in Korea, given the manufacturer's address).

3. Number of Experts and Qualifications for Ground Truth of Test Set:

There is no mention of human experts being used to establish ground truth for a test set of clinical images. The provided information describes non-clinical performance testing using quantitative metrics (DQE, MTF, NPS, Contrast, Noise, CNR) and comparison to the predicate device, as well as a "Clinical consideration and Image Quality Evaluation Report" which "demonstrated that the general image quality of the subject device is equivalent or better than the predicate device in PANO/CBCT mode." However, details on how this "Clinical consideration" was performed (e.g., blinded review by experts, number of experts, their qualifications, or what "ground truth" they used) are not provided in this summary.

4. Adjudication Method for the Test Set:

Not applicable as the testing described is primarily non-clinical and does not involve human readers or a clinical test set requiring adjudication in the context of diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focuses on equivalence through non-clinical performance metrics and comparison to a predicate device, not on how human readers' performance improves with or without the device.

6. Standalone Performance:

Yes, performance data for the standalone device/detector was done. The document outlines bench testing of the Xmaru1524CF Master Plus OP detector and the Green X 18 system itself, measuring metrics such as pixel size, DQE, MTF, NPS, Contrast, Noise, CNR, and DAP. These measurements represent the algorithm-only/device-only performance in a controlled environment.

7. Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" was established by physical standards and quantitative measurements in a laboratory setting, comparing the device's performance against industry standards (e.g., 21 CFR Part 1020.30, 1020.33, IEC 61223-3-5, IEC 61223-3-4) and the performance of the predicate device.
For the "Clinical consideration and Image Quality Evaluation Report," the method for establishing ground truth is not detailed, but it would presumably involve expert review of images obtained from the device.

8. Sample Size for the Training Set:

No training set information is provided, as the submission describes a medical imaging device (X-ray system), not an AI algorithm that requires a training set of images. The "image reconstruction/MAR(Metal Artifact Reduction) algorithm" is mentioned as being the same as the predicate device, implying it was developed prior and is not a new algorithm requiring a new training study for this submission.

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

Not applicable, as this is an imaging device and not an AI algorithm requiring a training set with established ground truth.

Summary

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February 18, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Vatech Co., Ltd % Mr. Dave Kim Contact Title Medical Device Regulatory Affairs Mtech Group 7707 Fannin St., Ste. 200-V111 HOUSTON TX 77054

Re: K210329

Trade/Device Name: Green X 18(Model: PHT-75CHS) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: February 1, 2021 Received: February 4, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210329

Device Name

Green X 18 (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 K210329

1. Traditional 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 15, 2021

3. Administrative Information

Official Correspondent:	Dave Kim / Mtech GroupAddress: 7707 Fannin St. Ste 200, V-111, Houston, TX 77054Tel: +713-467-2607Contact 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)

4. Device Information

Type of 510(k) Submission:	Special
Trade or Proprietary Name:	Green X 18 (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

7. Indication for use

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8. Substantial Equivalence Chart

	Subject Device	Predicate Device
Device Name	Green X 18 (Model: PHT-75CHS)	Green X (Model: PHT-75CHS)
Applicant Name	VATECH Co., Ltd.	VATECH Co., Ltd.
510(k) Number	K210329	K201627
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
Indications for Use	Green X 18 (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 operatedby healthcare 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 operatedby healthcare professionals.
Performance Specification	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. 18.0 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 Viewing Program	EzDent-i (K202116)	EzDent-i (K202116)
3D Image Viewing Program	Ez3D-i (K200178)	Ez3D-i (K200178)
Anatomical Sites	Maxillofacial	Maxillofacial
Image Receptor	CT&PANOXmaru1524CF Master Plus OPCEPHXmaru2602CF	Xmaru1314CFXmaru2602CF
Size of Imaging Volume	Xmaru1524CF Master Plus OPMax. 180 x 150 mm	Xmaru1314CFMax. 160 x 90 mm
Pixel Resolution	CT&PANOXmaru1524CF Master Plus OP5 lp/mm -2x2 binning2.5 lp/mm -4x4 binning	Xmaru1314CF5 lp/mm -2x2 binning2.5 lp/mm -4x4 binning
	CEPH5 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&PANOXmaru1524CF Master Plus OP99 μm -2X2 binning198 μm - 4X4 binning	Xmaru1314CF99 μm -2X2 binning198 μm - 4X4 binning
	CEPH100 μm- Non binning (detector spec)	100 μm- Non binning (detector spec)

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9. Performance Data

- Summary of Performance Testing

The Green X 18 (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, Xmaru1524CF-Master Plus OP.

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 (K202116) and Ez3D-i (K200178). 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 subject device is equipped with a new detector, Xmaru1524CF Master Plus OP which captures an image in panoramic, CBCT and Model Scan mode.

Based on Non-Clinical Test results of the new detector Xmaru1524 Master Plus OP, the measured pixel sizes of the new sensor (Xmaru1524 Master Plus OP) are very similar to that of the predicate device (Xmaru1314CF). Therefore, compared to the predicate device, the test patterns of the new sensor images show the test subjects without aliasing phenomenon throughout the same spatial frequency as the predicate device. Moreover, the new Xmaru1524CF Master Plus OP sensor has performed similarly or better than the predicate device in terms of the overall DQE performance, given the DQE variation in low frequency ( ~ 0.5 lp/mm). At a low spatial frequency (r0.5 lp/mm), Xmaru1524CF Master Plus OP has the DQE of 41% (4x4binning) whereas Xmaru1314CF has 36% (4x4binning). The new sensor also exhibits similar performances in terms of MTF and NPS. In conclusion, the diagnostic image quality of the new sensor is equal or better than those of the predicate device and there is no significant difference in terms of efficiency and safety.

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 or better than 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 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 subject device and the predicate device has the same FDD(Focal Spot to Detector Distance) and exposure conditions (exposure time, tube voltage, tube current) was the same. DAP measurements compared at different FOV sizes (12x9/8x8/8x5/5x5 cm) were equivalent.

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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 or better than 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.

Green X 18 (Model: PHT-75CHS) provides the following imaging viewer programs;

-2D Image viewing program: EzDent-i(K202116)
-3D Image viewing program: Ez3D-i(K200178)

- 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 (Edition 1.1) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2014 (Edition 4). 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 18 (Model : PHT-75CHS) 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. Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, Performance Testing – Bench" were performed. Acceptance test and Image evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were also performed.

All test results were satisfactory.

10. Conclusions

Safety and effectiveness of the above hardware modifications 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. As demonstrated in the performance test, the Xmaru1524CF Master Plus OP performed equivalent or better in comparison with the predicate device in various performance parameters such as DQE, MTF and NNPS. In addition, image quality of new X-ray detector has been evaluated in compliance with IEC 61223-3-4 and IEC 61223-3-5. Both standard requirements were satisfied.

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, VATECH Co., Ltd. concludes that Green X 18 (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.