Vantage Fortian/Orian 1.5T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

Proton density (PD) (also called hydrogen density)
Spin-lattice relaxation time (T1)
Spin-spin relaxation time (T2)
Flow dynamics
Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

Device Description

The Vantage Fortian (Model MRT-1550/WK, WM, WO, WQ)/Vantage Orian (Model MRT-1550/U3, U4, U7, U8) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. These Vantage Fortian/Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo™ Sigma and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Fortian/Orian models provide the maximum field of view of 55 x 55 x 50 cm and include the standard (STD) gradient system.

The Vantage Orian (Model MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo™ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Orian models provide the maximum field of view of 55 x 55 x 50 cm. The Model MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP includes the XGO gradient system.

This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Fortian/Orian MRI System is comparable to the current 1.5T Vantage Fortian/Orian MRI System (K240238), cleared April 12, 2024, with the following modifications.

AI/ML Overview

Acceptance Criteria and Study for Canon Medical Systems Vantage Fortian/Orian 1.5T with AiCE Reconstruction Processing Unit for MR

This document outlines the acceptance criteria and the study conducted to demonstrate that the Canon Medical Systems Vantage Fortian/Orian 1.5T with AiCE Reconstruction Processing Unit for MR (V10.0) device meets these criteria, specifically focusing on the new features: 4D Flow, Zoom DWI, and PIQE.

The provided text focuses on the updates in V10.0 of the device, which primarily include software enhancements: 4D Flow, Zoom DWI, and an extended Precise IQ Engine (PIQE). The acceptance criteria and testing are described for these specific additions.

1. Table of Acceptance Criteria and Reported Device Performance

The general acceptance criterion for all new features appears to be demonstrating clinical acceptability and performance that is either equivalent to or better than conventional methods, maintaining image quality, and confirming intended functionality. Specific quantitative acceptance criteria are not explicitly detailed in the provided document beyond qualitative assessments and comparative statements.

Feature	Acceptance Criteria (Implied from testing)	Reported Device Performance
4D Flow	Velocity measurement with and without PIQE of a phantom should meet the acceptance criteria for known flow values. Images in volunteers should demonstrate velocity stream lines consistent with physiological flow.	The testing confirmed that the flow velocity of the 4DFlow sequence met the acceptance criteria. Images in volunteers demonstrated velocity stream lines.
Zoom DWI	Effective suppression of wraparound artifacts in the PE direction. Reduction of image distortion level when setting a smaller PE-FOV. Accurate measurement of ADC values.	Testing confirmed that Zoom DWI is effective for suppressing wraparound artifacts in the PE direction; setting a smaller PE-FOV in Zoom DWI scan can reduce the image distortion level; and the ADC values can be measured accurately.
PIQE (Bench Testing)	Generate higher in-plane matrix images from low matrix images. Mitigate ringing artifacts. Maintain similar or better contrast and SNR compared to standard clinical techniques. Achieve sharper edges.	Bench testing demonstrated that PIQE generates images with sharper edges while mitigating the smoothing and ringing effects and maintaining similar or better contrast and SNR compared to standard clinical techniques (zero-padding interpolation and typical clinical filters).
PIQE (Clinical Image Review)	Images reconstructed with PIQE should be scored clinically acceptable or better by radiologists/cardiologists across various categories (ringing, sharpness, SNR, overall image quality (IQ), and feature conspicuity). PIQE should generate higher spatial in-plane resolution images from lower resolution images (e.g., triple matrix dimensions, 9x factor). PIQE should contribute to ringing artifact reduction, denoising, and increased sharpness. PIQE should be able to accelerate scanning by reducing acquisition matrix while maintaining clinical matrix size and image quality. PIQE benefits should be obtainable on regular clinical protocols without requiring acquisition parameter adjustment. Reviewer agreement should be strong.	The resulting reconstructions were scored on average at, or above, clinically acceptable. Exhibiting a strong agreement at the "good" and "very good" level in the IQ metrics, the Reviewers' scoring confirmed all the specific criteria listed (higher spatial resolution, ringing reduction, denoising, sharpness, acceleration, and applicability to regular protocols).

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

4D Flow & Zoom DWI: Evaluated utilizing phantom images and "representative volunteer images." Specific numbers for volunteers are not provided.
PIQE Clinical Image Review Study:
- Subjects: A total of 75 unique subjects.
- Scans: Comprising a total of 399 scans.
- Reconstructions: Each scan was reconstructed multiple ways with or without PIQE, totaling 1197 reconstructions for scoring.
- Data Provenance: Subjects were from two sites in USA and Japan. The study states that although the dataset includes subjects from outside the USA, the population is expected to be representative of the intended US population due to PIQE being an image post-processing algorithm that is not disease-specific and not dependent on factors like population variation or body habitus.

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

PIQE Clinical Image Review Study:
- Number of Experts: 14 USA board-certified radiologists/cardiologists.
- Distribution: 3 experts per anatomy (Body, Breast, Cardiac, Musculoskeletal (MSK), and Neuro).
- Qualifications: "USA board-certified radiologists/cardiologists." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

PIQE Clinical Image Review Study: The study describes a randomized, blinded clinical image review study. Images reconstructed with either the conventional method or the new PIQE method were randomized and blinded to the reviewers. Reviewers scored the images independently using a modified 5-point Likert scale. Analytical methods used included Gwet's Agreement Coefficient for reviewer agreement and Generalized Estimating Equations (GEE) for differences between reconstruction techniques, implying a statistical assessment of agreement and comparison across reviewers rather than a simple consensus adjudication method (e.g., 2+1, 3+1).

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

Yes, an MRMC comparative effectiveness study was done for PIQE.
Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance: The document states that "the Reviewers' scoring confirmed that: (a) PIQE generates higher spatial in-plane resolution images from lower resolution images (with the ability to triple the matrix dimensions in both in-plane directions, i.e. a factor of 9x); (b) PIQE contributes to ringing artifact reduction, denoising and increased sharpness; (c) PIQE is able to accelerate scanning by reducing the acquisition matrix only, while maintaining clinical matrix size and image quality; and (d) PIQE benefits can be obtained on regular clinical protocols without requiring acquisition parameter adjustment."
- While it reports positive outcomes ("scored on average at, or above, clinically acceptable," "strong agreement at the 'good' and 'very good' level"), it does not provide a quantitative effect size (e.g., AUC difference, diagnostic accuracy improvement percentage) of how much human readers improve with AI (PIQE) assistance compared to without it. The focus is on the quality of PIQE-reconstructed images as perceived by experts, rather than the direct impact on diagnostic accuracy or reader performance metrics. It confirms that the performance is "similar or better" compared to conventional methods.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance was conducted for PIQE and other features.
- 4D Flow and Zoom DWI: Evaluated using phantom images, which represents standalone, objective measurement of the algorithm's performance against known physical properties.
- PIQE: Bench testing was performed on typical clinical images to evaluate metrics like Edge Slope Width (sharpness), Ringing Variable Mean (ringing artifacts), Signal-to-Noise ratio (SNR), and Contrast Ratio. This is an algorithmic-only evaluation against predefined metrics, without direct human interpretation as part of the performance metric.

7. Type of Ground Truth Used

4D Flow & Zoom DWI:
- Phantom Studies: Known physical values (e.g., known flow values for velocity measurement, known distortion levels, known ADC values).
PIQE:
- Bench Testing: Quantitative imaging metrics derived from the images themselves (Edge Slope Width, Ringing Variable Mean, SNR, Contrast Ratio) are used to assess the impact of the algorithm. No external ground truth (like pathology) is explicitly mentioned here, as the focus is on image quality enhancement.
- Clinical Image Review Study: Expert consensus/opinion (modified 5-point Likert scale scores from 14 board-certified radiologists/cardiologists) was used as the ground truth for image quality, sharpness, ringing, SNR, and feature conspicuity, compared against images reconstructed with conventional methods. No pathology or outcomes data is mentioned as ground truth.

8. Sample Size for the Training Set

The document explicitly states that the 75 unique subjects used in the PIQE clinical image review study were "separate from the training data sets." However, it does not specify the sample size for the training set used for the PIQE deep learning model.

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

The document does not provide information on how the ground truth for the training set for PIQE was established. It only mentions that the study test data sets were separate from the training data sets.

Summary

FDA 510(k) Clearance Letter - Canon Medical Systems

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 22, 2025

Canon Medical Systems Corporation
℅ Blake Stacy
Manager, Regulatory Affairs
Canon Medical Systems USA, Inc.
2441 Michelle Drive
Tustin, California 92780

Re: K250901
Trade/Device Name: Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic Resonance Diagnostic Device
Regulatory Class: Class II
Product Code: LNH
Dated: July 2, 2025
Received: July 2, 2025

Dear Blake Stacy:

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 (the 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 available 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.

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K250901 - Blake Stacy
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250901 - Blake Stacy
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assistance/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,

Ningzhi Li -S Digitally signed by Ningzhi Li -S

for
Daniel M. Krainak, PhD
Assistant Director
DHT8C: Division of Radiological Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

510(k) Number (if known): K250901

Device Name: Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

Indications for Use (Describe)

Proton density (PD) (also called hydrogen density)
Spin-lattice relaxation time (T1)
Spin-spin relaxation time (T2)
Flow dynamics
Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

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2441 Michelle Drive, Tustin, CA 92780
PHONE: 800-421-1968
https://us.medical.canon

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.

1. CLASSIFICATION and DEVICE NAME

Classification Name: Magnetic Resonance Diagnostic Device
Regulation Number: 90-LNH (Per 21 CFR § 892.1000)
Trade Proprietary Name: Vantage Fortian / Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Model Number: MRT-1550

2. SUBMITTER'S NAME

Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-Shi, Tochigi-ken, Japan 324-8550

3. OFFICIAL CORRESPONDENT

Naofumi Watanabe
Senior Manager, Regulatory Affairs and Vigilance
Canon Medical Systems Corporation

4. CONTACT PERSON, U.S. AGENT and ADDRESS

Contact Person

Blake Stacy
Manager, Regulatory Affairs, Canon Medical Systems USA, Inc.
2441 Michelle Drive, Tustin, CA 92780
Phone: (626) 319-9444
Fax: (714) 730-1310
E-mail: bstacy@us.medical.canon

Official Correspondent/U.S. Agent

Orlando Tadeo, Jr.
Director, Regulatory Affairs, Canon Medical Systems USA, Inc.
2441 Michelle Drive, Tustin, CA 92780
Phone: (714) 669-7459
Fax: (714) 730-1310
E-mail: otadeo@us.medical.canon

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Canon Medical Systems USA, Inc.

5. MANUFACTURING SITE

Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi 324-8550, Japan

6. ESTABLISHMENT REGISTRATION

9614698

7. DATE PREPARED

March 25, 2025

8. DEVICE NAME

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

9. TRADE NAME

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

10. CLASSIFICATION NAME

Magnetic Resonance Diagnostic Device (MRDD)

11. CLASSIFICATION PANEL

Radiology

12. DEVICE CLASSIFICATION

Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)

13. PRODUCT CODE

90-LNH

14. PREDICATE DEVICE

Predicate Device: Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR (K240238)

System	Predicate Device
	Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
Marketed By	Canon Medical Systems USA, Inc.
510(k) Number	K240238
Clearance Date	April 12, 2024

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Canon Medical Systems USA, Inc.

15. REFERENCE DEVICE

Reference Device: Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K243335)

System	Reference Device
	Vantage Galan 3T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Marketed By	Canon Medical Systems USA, Inc.
510(k) Number	K243335
Clearance Date	January 7, 2025

16. REASON FOR SUBMISSION

Modification of a cleared device

17. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

18. DEVICE DESCRIPTION

The Vantage Fortian (Model MRT-1550/WK, WM, WO, WQ)/Vantage Orian (Model MRT-1550/U3, U4, U7, U8) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. These Vantage Fortian/Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo™ Σ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Fortian/Orian models provide the maximum field of view of 55 x 55 x 50 cm and include the standard (STD) gradient system.

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Canon Medical Systems USA, Inc.

19. SUMMARY OF CHANGE(S)

This submission is to report the following changes:

Summary of Software Changes:

4D Flow: 4D Flow Application provides the function of visualization of blood flow conditions by combining with external analytical software. Quantitative analysis such as streamline, path line, and velocity is available. Moreover, either Cine or Retro can be used together in PS3D, and PS images with time-phase information can be obtained.
Zoom DWI: Zoom DWI Application offers diffusion images of smaller FOV size by selective excitation and outer volume suppression (OVS). This application proposes to remove the distortion and the aliasing artifact in PE direction.
Precise IQ Engine (PIQE): PIQE is a Deep Learning based technique that generates higher in-plane matrix images from low matrix images while mitigating the ringing artifact. PIQE has been extended to multiple scan families, weightings, and additional anatomical areas.
System Software: Minor updates were made to the system software.

Summary of Accessory Changes:

Breast SPEEDER pad kit: Newly added, optional patient support to be used with Breast SPEEDER RF coil.

20. SAFETY PARAMETERS

Item	Subject Device: Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR	Predicate Device: Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR	Notes
Static field strength	1.5T	1.5T	Same
Operational Modes	Normal and 1st Operating Mode	Normal and 1st Operating Mode	Same
i. Safety parameter display	SAR, dB/dt	SAR, dB/dt	Same
ii. Operating mode access requirements	Allows screen access to 1st level operating mode	Allows screen access to 1st level operating mode	Same
Maximum SAR	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015)	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015)	Same
Maximum dB/dt	1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015	1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015	Same
Potential emergency condition and means provided for shutdown	Shutdown by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects	Shutdown by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects	Same

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Canon Medical Systems USA, Inc.

21. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K240238.

22. INDICATIONS FOR USE

Proton density (PD) (also called hydrogen density)
Spin-lattice relaxation time (T1)
Spin-spin relaxation time (T2)
Flow dynamics
Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

*Note: No change from the predicate submission, K240238

23. SUMMARY OF DESIGN CONTROL ACTIVITIES

Risk Management activities for this modification are included in this submission. The test methods used are the same as those submitted in the previously cleared submission of the predicate device, Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR (K240238). A declaration of conformity with design controls is included in this submission.

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Canon Medical Systems USA, Inc.

24. SAFETY

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards.

This device is based upon the same technologies, materials and software as the predicate device. Risk activities were conducted in concurrence with established medical device development standards and guidance. Additionally, testing was done in accordance with applicable recognized consensus standards published by the International Electrotechnical Commission (IEC) for medical devices and the National Electrical Manufacturers Association (NEMA):

LIST OF APPLICABLE STANDARDS

ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
IEC 60601-1:2005, A1:2012, A2:2020
IEC 60601-1-2:2014+A1:2020
IEC 60601-1-6 (2010), Amd.1 (2013), Amd.2 (2020)
IEC 60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015)
IEC 60825-1 (2014)
IEC 62304 (2006), Amd.1 (2015)
IEC 62366-1 (2020)
ISO 10993-1 (2018)
NEMA MS 1:2008 (R2020)
NEMA MS 2:2008 (R2020)
NEMA MS 3:2008 (R2020)
NEMA MS 4 (2010)
NEMA MS 5 (2018)

25. TESTING

Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrate that the system requirements have been met. Additionally, image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria.

4D Flow was evaluated utilizing phantom images and representative volunteer images. Bench testing included velocity measurement with and without PIQE of a phantom with known flow values. Additionally, images in volunteers demonstrated velocity stream lines. The testing confirmed that the flow velocity of the 4DFlow sequence met the acceptance criteria.

Zoom DWI was evaluated utilizing phantom images and representative volunteer images. Testing confirmed that Zoom DWI is effective for suppressing wraparound artifacts in the PE direction; setting a smaller PE-FOV in Zoom DWI scan can reduce the image distortion level; and the ADC values can be measured accurately.

PIQE (Precise IQ Engine) for MR was not altered from the previously cleared version, but was extended to include additional scanning techniques, image weightings, and anatomical locations. PIQE underwent the same performance testing established in the predicate submission (K240238) as applied to each of the new anatomical regions. The same methodology for extension was applied in the reference submission, K243335. PIQE testing on the subject device included bench testing, performed on typical clinical images from Body, Breast, Cardiac, musculoskeletal (MSK), and Neuro, wherein the metrics of Edge Slope Width (to evaluate image sharpness), Ringing Variable Mean (to evaluate ringing artifacts), Signal-to-Noise ratio, and Contrast Ratio were evaluated. Comparing images with PIQE at various

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Canon Medical Systems USA, Inc.

scaling factors to standard clinical techniques, such as zero-padding interpolation and typical clinical filters, confirmed that PIQE generates images with sharper edges while mitigating the smoothing and ringing effects and maintaining similar or better contrast and SNR.

PIQE Performance Testing - Clinical Image Review Study

Additionally, a multi-site, randomized, blinded clinical image review study was conducted with 14 USA board-certified radiologists/cardiologists (3 per anatomy). Using the conventional method (i.e., matrix expansion with Fine Reconstruction and processing with typical clinical filter) as a reference, the images reconstructed with either the conventional method or the new PIQE method were randomized, blinded to the reviewers, and scored by 3 reviewers per anatomy in various clinically-relevant categories (including ringing, sharpness, SNR, overall image quality (IQ), and feature conspicuity) using a modified 5-point Likert scale. A total of 75 unique subjects, from two sites in USA and Japan, were scanned in body, breast, cardiac, musculoskeletal, or neuro to provide the test data sets (separate from the training data sets) using Vantage Orian or Fortian 1.5T and anatomy-appropriate coils, comprising a total of 399 scans, in multiple orientations, and multiple contrast weightings within the multiple families of pulse sequences. Each scan was reconstructed multiple ways with or without PIQE, totaling 1197 reconstructions to be scored. Reviewer scoring data was analyzed for reviewer agreement and differences between reconstruction techniques using Gwet's Agreement Coefficient and Generalized Estimating Equations (GEE), respectively. The resulting reconstructions were scored on average at, or above, clinically acceptable. Exhibiting a strong agreement at the "good" and "very good" level in the IQ metrics, the Reviewers' scoring confirmed that: (a) PIQE generates higher spatial in-plane resolution images from lower resolution images (with the ability to triple the matrix dimensions in both in-plane directions, i.e. a factor of 9x); (b) PIQE contributes to ringing artifact reduction, denoising and increased sharpness; (c) PIQE is able to accelerate scanning by reducing the acquisition matrix only, while maintaining clinical matrix size and image quality; and (d) PIQE benefits can be obtained on regular clinical protocols without requiring acquisition parameter adjustment.

Although the dataset of this multinational study includes subjects from outside the USA, the population is expected to be representative of the intended US population as it pertains to the intended use of the PIQE product. PIQE is an image post-processing algorithm that is not disease-specific and is not dependent on factors that would be relevant for scan acquisition or diagnosis-specific algorithms. The PIQE algorithm is not directly dependent on acquisition parameters that might be affected by population variation (such as body habitus). Indeed, the current study design is based on reconstructing each k-space acquisition multiple times (both with and without PIQE) such that all comparisons are internal, with each subject as its own control. So, patient-variable influences should be removed as a factor. For PIQE, where matrix expansion (pixel size) and edge sharpness are key, the relevant characteristics are primarily tissue structure, feature definition, and edge definition; and to some extent matrix size and FOV. Thus, related to the anatomies of interest, relevant features do not vary significantly from country to country. Further, even if the internal structures themselves are different, or differently distributed, across countries, the edge definition of such structures are not expected to vary differently patient-to-patient due to nationality.

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Canon Medical Systems USA, Inc.

Software Documentation for a Basic Documentation Level, per the FDA guidance document, "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, is included in this submission. This documentation includes justification for the Basic Documentation Level determination as well as testing which demonstrates that the verification and validation requirements have been met.

Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued on September 27, 2023, is also included as part of this submission.

26. SUBSTANTIAL EQUIVALENCE

Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Fortian/Orian 1.5T, MRT-1550, V10.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR, are substantially equivalent to the previously cleared predicate device.

27. CONCLUSION

The modifications incorporated into the Vantage Fortian/Orian 1.5T, MRT-1550, V10.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR, do not change the indications for use or the intended use of the device. Based upon the evidence presented, Canon Medical Systems Corporation considers the subject Vantage Fortian / Orian 1.5T device to be as safe, as effective, and with performance that is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.