This device is indicated to acquire and display cross-sectional volumes of the whole the head, with the capability to image whole organs in a single rotation. Whole organs include, but are not limited to brain, heart, pancreas, etc.

The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software, of the whole organ by a trained and qualified physician.

FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.

AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, inner ear and extremities applications.

The Spectral Imaging System allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The X-ray dose will be the sum of the dose at each respective tube voltage and current in a rotation.

Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies.

When used by a qualified physician, a potential application is to determine the course of treatment.

Device Description

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list numerical "acceptance criteria" in the format of a table with pass/fail thresholds. Instead, it describes various tests and claims that demonstrate substantial equivalence to previously cleared devices. The performance is reported in terms of qualitative assessments (e.g., "diagnostic quality," "substantially equivalent") and quantitative improvements (e.g., "dose reduction," "improvement in low contrast detectability," "noise reduction").

Here's an interpretation of the implied acceptance criteria and reported performance:

Feature/Claim Tested	Implied Acceptance Criteria	Reported Device Performance
Spectral Imaging
Image Quality (Bench)	Substantially equivalent or improved Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-Wire, Standard Deviation of Noise (SD), Noise Power Spectra (NPS), and Low Contrast Detectability (LCD) compared to predicate.	Spectral Images are substantially equivalent to the predicate device for all assessed metrics (CNR, CT Number Accuracy, Uniformity, SSP, MTF-Wire, SD, NPS, LCD).
Artifact Reduction Claim	Spectral Imaging reduces beam hardening artifact (relative to AIDR3D/FBP).	Spectral Imaging reduces beam hardening artifact (relative to AIDR3D/FBP).
Iodine Correlation Claim	High linear correlation between CT number and iodine concentration.	High linear correlation between CT number and iodine concentration demonstrated.
Clinical Image Quality	Spectral Images for abdomen/pelvis, lung, and extremity applications are of diagnostic quality.	Representative abdomen/pelvis, lung, and extremity Spectral Images were confirmed to be of diagnostic quality by an American Board Certified Radiologist.
AiCE
Image Quality (Bench)	Substantially equivalent or improved CNR, CT Number Accuracy, Uniformity, SSP, MTF-Wire, SD, NPS, LCD, and pediatric phantom/protocol performance compared to predicate.	AiCE is substantially equivalent to the predicate device for all assessed metrics (CNR, CT Number Accuracy, Uniformity, SSP, MTF-Wire, SD, NPS, LCD, pediatric phantom/protocol).
Dose Reduction Claim	Demonstrate significant dose reduction compared to filtered back projection (FBP) for body AiCE.	69-81% dose reduction compared to filtered back projection for body AiCE.
LCD Improvement Claim	Demonstrate improvement in low contrast detectability for body AiCE.	18.4% improvement in low contrast detectability for body AiCE.
Noise Reduction Claim	Demonstrate noise reduction at the same dose for body AiCE compared to AIDR 3D.	32% noise reduction at the same dose for body AiCE compared to AIDR 3D.
Artifact Appearance Claim	No introduction of additional artifacts and similar appearance to FBP and AIDR 3D for streak and beam hardening artifacts.	Streak and beam hardening artifacts appeared the same with AiCE as when FBP and AIDR 3D were used and additional artifacts were not introduced.
Spatial Resolution Claim	Improved high contrast spatial resolution of AIDR 3D with reduced noise for AiCE Body Sharp at 10% of the MTF.	Twice the high contrast spatial resolution of AIDR 3D with reduced noise for AiCE Body Sharp at 10% of the MTF.
Noise Appearance Claims	AiCE noise appearance/texture should be: - More similar to high dose FBP (compared to FIRST); - More similar to FBP (compared to FIRST); - Improved (compared to FIRST); - More natural (compared to FIRST).	AiCE noise appearance/texture: - More similar to high dose filtered backprojection (compared to FIRST); - More similar to filtered backprojection (compared to FIRST); - Improved (compared to FIRST); - More natural (compared to FIRST).
Clinical Image Quality	AiCE images for abdomen/pelvis, brain, inner ear, and extremity applications are of diagnostic quality.	Representative abdomen/pelvis, brain, inner ear and extremity AiCE images were confirmed to be of diagnostic quality by an American Board Certified Radiologist.

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

Spectral Imaging Performance Testing - Bench: The sample size for phantoms used in bench testing is not specified beyond "various phantoms" and "Catphan and Body Phantom." Data provenance is laboratory bench testing.
Spectral Imaging Performance Testing - Clinical Images: The sample size is not specified beyond "Representative abdomen/pelvis, lung, and extremity Spectral Images." The data provenance of these clinical images (country of origin, retrospective/prospective) is not specified in the provided text.
Non-Spectral Imaging and AiCE Performance Testing - Bench: The sample size for phantoms used in bench testing is not specified beyond "various phantoms." Data provenance is laboratory bench testing.
AiCE Imaging Performance Testing - Clinical Images: The sample size is not specified beyond "Representative abdomen/pelvis, brain, inner ear and extremity AiCE images." The data provenance of these clinical images (country of origin, retrospective/prospective) is not specified in the provided text.

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

For both Spectral Imaging Clinical Images and AiCE Clinical Images: "an American Board Certified Radiologist" was used. This indicates one expert. The specific years of experience are not mentioned, but "American Board Certified" signifies a high level of qualification.

4. Adjudication Method for the Test Set

For both Spectral Imaging Clinical Images and AiCE Clinical Images, only one expert (an American Board Certified Radiologist) reviewed the images. Therefore, there was no adjudication method between multiple experts employed for these clinical image quality assessments. The phrase "it was confirmed" implies a singular decision.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not explicitly mentioned in the provided text for evaluating human reader improvement with AI assistance. The clinical image reviews were done by a single radiologist to confirm "diagnostic quality" of the AI-processed images, not to compare human reader performance with and without AI. The quantitative performance (dose reduction, LCD improvement, noise reduction) was assessed via model observer evaluation or phantom studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, extensive standalone performance testing was done for both Spectral Imaging and AiCE.
- Spectral Imaging: Bench testing utilizing phantoms assessed various image quality metrics (CNR, CT Number Accuracy, Uniformity, SSP, MTF-Wire, SD, NPS, LCD) to demonstrate substantial equivalence to the predicate. Other phantom studies supported claims of beam hardening artifact reduction and iodine concentration correlation.
- AiCE: Bench testing utilizing phantoms assessed similar image quality metrics and pediatric phantom/protocol performance, demonstrating substantial equivalence. A model observer evaluation was specifically mentioned for quantitative assessments of dose reduction, LCD improvement, and noise reduction compared to FBP and AIDR 3D, which is a standalone algorithm-only performance assessment. Other phantom studies supported claims regarding artifact appearance, spatial resolution, and noise appearance/texture.

7. The Type of Ground Truth Used

For Bench Testing (Spectral and AiCE): The ground truth was based on physical phantom measurements and known properties/compositions of the phantoms. For example, known concentrations of materials for iodine correlation, or predefined structures for MTF and LCD assessments.
For Clinical Image Reviews (Spectral and AiCE): The ground truth was expert consensus (single expert), specifically the judgment of an American Board Certified Radiologist that the images were of "diagnostic quality." This is a form of expert opinion or interpretation.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set for either AiCE (Deep Convolutional Neural Network) or FIRST (Iterative Reconstruction Algorithm). It only mentions that AiCE employs "Deep Convolutional Neural Network methods."

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

The document does not provide details on how the ground truth for the training set was established. It mentions the use of "Deep Convolutional Neural Network methods" for AiCE, which implies a supervised learning approach requiring labeled training data, but the specifics of that labeling process or who performed it are omitted.

Summary

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February 13, 2020

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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K192828

Trade/Device Name: Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: December 30, 2019 Received: December 31, 2019

Dear Mr. Tadeo:

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)

K192828

Device Name

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

Indications for Use (Describe)

FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.

Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies.

When used by a qualified physician, a potential application is to determine the course of treatment.

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image contains the text "K192828" on the top line, with the phrase "Made For life" on the second line. The text is in a simple, sans-serif font, with the phrase "Made For life" in a slightly larger and bolder font than the code above it. The text is black against a white background.

510(k) SUMMARY

1. SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
1. OFFICIAL CORRESPONDENT: Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
1. ESTABLISHMENT REGISTRATION: 9614698

4. CONTACT PERSON:

Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459

1. DATE PREPARED:
  September 30, 2019
1. TRADE NAME(S): Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

7. COMMON NAME:

System, X-ray, Computed Tomography

8. DEVICE CLASSIFICATION:

a) Classification Name: Computed Tomography X-ray system b) Regulation Number: 892.1750 c) Regulatory Class: Class II

9. PRODUCT CODE / DESCRIPTION:

JAK / Computed Tomography X-Ray System

PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780

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10. PREDICATE DEVICE:

Product	Marketed by	RegulationNumber	RegulationName	Product Code	510(k)Number	ClearanceDate
Primary:Aquilion ONE (TSX-306A/3) V10.0	CanonMedicalSystems, USA	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K192188	09/06/2019
Reference:Aquilion ONE (TSX-305A/6) V8.9 withAiCE	CanonMedicalSystems, USA	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K183046	06/12/2019
Reference:Dual Energy SystemPackage, CSDP-001A	CanonMedicalSystems, USA	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K132813	02/06/2014
Reference:Revolution CT	GE MedicalSystems,L.L.C.	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K163213	12/16/2016

11. REASON FOR SUBMISSION:

Modification of existing medical device

12. DEVICE DESCRIPTION:

13. INDICATIONS FOR USE:

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include, but are not limited to brain, heart, pancreas, etc.

The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.

AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, brain, inner ear and extremities applications.

The Spectral Imaging System allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The Xray dose will be the sum of the dose at each respective tube voltage and current in a rotation.

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Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies. When used by a qualified physician, a potential application is to determine the course of treatment.

14. SUBSTANTIAL EQUIVALENCE:

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is substantially equivalent to Aquilion ONE (TSX-306A/3) V10.0, which received premarket clearance under K192188, and is marketed by Canon Medical Systems USA. The intended use of the Aquilion ONE is the same as that of the predicate device. The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System includes changes made to the predicate device including implementation of Spectral Imaging System, AiCE and FIRST. A comparison of the technological characteristics between the subject and the predicate device is included below.

	Subject Device	Predicate Device	Comment
Device Name,Model Number	Aquilion ONE(TSX-306A/3) V10.0 withSpectral Imaging System	Aquilion ONE(TSX-306A/3) V10.0
510(k) Number	This submission	K192188
Spectral Imaging System(CSDE-004A)	Available	N/A	Reference PredicateDevice: K132813
• Scan Type	-Rapid kV Switching		-Two consecutive volumescans with short tubevoltage switching
• Scan Regions	-Abdomen and pelvis,Chest and Extremities		-Whole Body
• Spectral ReconstructionImages	-Basis material image-Monochromatic image-Iodine Map-VNC (virtual non-contrast) image		N/A
Advanced Intelligent Clear-IQEngine (AiCE)	Available	N/A	Reference PredicateDevice: K183046
• Scan Regions	Abdomen and PelvisChestCardiacExtremitiesBrainInner ear*		Abdomen and PelvisChestCardiac*New scan regions
FIRST(Forward projected model-based Iterative ReconstructionSolution)	Available	N/A
Reconstruction processingunit (CCRS-003A*)	Available	N/A	* Includes FIRST and AiCE

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15. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the following standards IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA XR-25, NEMA XR-26 and NEMA XR-29. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.

This device conforms to applicable Performance Standards for lonizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

16. TESTING

Risk analysis and verification/validation activities conducted through bench testing demonstrate that the established specifications for the device have been met.

Spectral Imaging Performance Testing - Bench

Image Quality Evaluation

CT image quality metrics were performed, utilizing phantoms, to assess Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-Wire, Standard Deviation of Noise (SD), Noise Power Spectra (NPS) and Low Contrast Detectability (LCD). It was concluded that the Spectral Images are substantially equivalent to the predicate device as demonstrated by the results of the above testing.

Catphan and Body Phantom Evaluation

A side-by-side study was conducted to compare the image quality between the predicate dual energy scanning versus the subject Spectral Imaging scanning at varying dose levels.

Other studies using various phantoms were conducted to support the following Spectral Imaging claims:

। Spectral Imaging reduces beam hardening artifact (relative to AIDR3D/FBP)
। High linear correlation between CT number and iodine concentration

Spectral Imaging Performance Testing – Clinical Images

Representative abdomen/pelvis, lung, and extremity Spectral Images, reviewed by an American Board Certified Radiologist, were obtained using the subject device and it was confirmed that the Spectral Imaging reconstructed images using the subject device were of diagnostic quality.

Non-Spectral Imaging and AiCE Performance Testing – Bench

Image Quality Evaluation

CT image quality metrics were performed, utilizing phantoms, to assess Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP),

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Modulation Transfer Function (MTF)-Wire, Standard Deviation of Noise (SD), Noise Power Spectra (NPS), Low Contrast Detectability (LCD) and Pediatric phantom/protocol. It was concluded that AiCE is substantially equivalent to the predicate device as demonstrated by the results of the above testing.

Quantitative Body LCD, Noise Improvement, Dose Reduction

A model observer evaluation was conducted and the subject device demonstrated a dose reduction of 69-81% compared to filtered back projection, a 18.4% improvement in low contrast detectability and 32% noise reduction at the same dose for body AiCE compared to AIDR 3D.

Other studies using various phantoms were conducted to support the following claims:

Streak and beam hardening artifacts appeared the same with AiCE as when FBP and AIDR 3D were used and additional artifacts were not introduced
Twice the high contrast spatial resolution of AIDR 3D with reduced noise for AiCE Body Sharp at 10% of the MTF
AiCE noise appearance/texture more similar to high dose filtered backprojection (compared to FIRST)
AiCE noise appearance/texture more similar to filtered backprojection (compared to FIRST)
AiCE has improved noise appearance/texture (compared to FIRST)
AiCE has more natural noise texture (compared to FIRST)
Effective 144 (180 with option) kW max. equivalent generator power with AIDR

AiCE Imaging Performance Testing – Clinical Images

Representative abdomen/pelvis, brain, inner ear and extremity AiCE images were reviewed by an American Board Certified Radiologist. All images were obtained using the subject device and it was confirmed that the images were of diagnostic quality.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices " issued on October 2, 2014, is also included as part of this submission.

Additionally, testing of the subject device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.

17. CONCLUSION

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product labeling. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance

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data presented in this submission it is concluded that the subject device has demonstrated substantial equivalence to the predicate device and is safe and effective for its intended use.

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.