Vantage Galan 3T 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

Flow dynamics
Chemical Shift

·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 Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K192574. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study details based on the provided FDA 510(k) summary:

Analysis of Acceptance Criteria and Proving Study

The submission focuses on software changes and the substantial equivalence of the new device (Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR) to its predicate (Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR). The primary objective of the testing described is to demonstrate that the image quality and safety of the new software functionalities are maintained and are of diagnostic quality.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments / Supporting Evidence
Safety Parameters	Static field strength	3T	Same as predicate.
	Operational Modes	Normal and 1st Operating Mode	Same as predicate.
	Safety parameter display (SAR, dB/dt)	SAR, dB/dt	Same as predicate.
	Operating mode access requirements	Allows screen access to 1st level operating mode	Same as predicate.
	Maximum SAR	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015)	Same as predicate.
	Maximum dB/dt	1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015	Same as predicate.
	Potential emergency condition and means provided for shutdown	Shutdown by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects	Same as predicate.
Imaging Performance	Overall image noise	Maintained diagnostic quality	Representative volunteer images reviewed by experts.
	Image sharpness	Maintained diagnostic quality	Representative volunteer images reviewed by experts.
	Image degradation	Absence of significant degradation	Representative volunteer images reviewed by experts.
	Image artifacts	Absence of significant artifacts	Representative volunteer images reviewed by experts.
	Diagnostic contrast	Maintained diagnostic quality	Representative volunteer images reviewed by experts.
	Lesion/pathology conspicuity	Maintained diagnostic quality	Representative volunteer images reviewed by experts.
	Clinical utility	Images confirmed to be of diagnostic quality.	Representative volunteer images reviewed by experts.

Note: The document explicitly states "No change from the previous predicate submission, K192574" for Imaging Performance Parameters on page 6. However, the subsequent "TESTING" section (Page 7) describes objective image quality assessment for the new software functionalities (3D FAST sequences and 3D Compressed SPEEDER acceleration sequences) using expert review to demonstrate that diagnostic quality is maintained. This implies that the standard for image quality (diagnostic utility) serves as the implicit acceptance criterion.

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

Sample Size: The document mentions "volunteer images" and "representative images" were used. It does not explicitly state the numerical sample size (number of volunteers or images) for the image quality testing.
Data Provenance: The document does not specify the country of origin. The study appears to be prospective in the sense that the images were acquired using the subject device specifically for this evaluation using volunteers.

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

Number of Experts: The document states "American Board Certified Radiologists and American Board Certified Cardiologists with MR certification" were used. It does not specify the exact number of such experts.
Qualifications of Experts:
- American Board Certified Radiologists
- American Board Certified Cardiologists with MR certification
- No information on their years of experience is provided.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). It describes "Reviewers provided detailed assessments," suggesting individual reviews contributed to the confirmation of diagnostic quality. It does not mention whether multiple reviewers were involved in assessing the same images and how disagreements were resolved.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess how much human readers improve with AI vs. without AI assistance. The study described focuses on confirming the diagnostic quality of images produced by the device with new software features, not on the impact of AI assistance on human reader performance. The "AiCE Reconstruction Processing Unit" is part of the core device functionality being assessed, not an AI assist to human interpretation in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The study described is an assessment of the image quality produced by the device, which includes the AiCE Reconstruction Processing Unit. The expert review confirms the diagnostic quality of these images. This is an evaluation of the algorithm's output, but it's not a standalone diagnostic performance study in the sense of the algorithm making an independent diagnosis. The device generates images to be interpreted by a trained physician. The study confirms the output (images) is of diagnostic quality, which could be considered a form of standalone performance for the image reconstruction aspect.

7. Type of Ground Truth Used

The ground truth used for evaluating image quality appears to be expert consensus/opinion regarding "diagnostic quality," "overall image noise," "image sharpness," "image degradation," "image artifacts," "diagnostic contrast," and "lesion/pathology conspicuity." This is derived from the subjective and objective assessment of the images by the certified radiologists and cardiologists. There is no mention of pathology findings or long-term outcomes data being used as ground truth for this particular study.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set used for the AiCE (Artificial intelligence-enhanced Reconstruction) component of the device. This information is typically found in the development or validation sections of the submission, but not in this summary.

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

The document does not provide any information on how the ground truth for the training set for the AiCE component was established.

Summary

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Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 2, 2021

Canon Medical Systems Corporation % Ms. Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K203553

Trade/Device Name: Vantage Galan 3T, MRT-3020, V7.0 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: December 2, 2020 Received: December 4, 2020

Dear Ms. Reyes:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 medical devices and radiation-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

Device Name

Vantage Galan 3T, MRT-3020, V7.0 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

Flow dynamics
Chemical Shift

·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."

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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 Galan 3T, MRT-3020, V7.0 with AiCE ReconstructionProcessing Unit for MR
Model Number:	MRT-3020

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

Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 E-mail: jfreyes@us.medical.canon

Official Correspondent/U.S. Agent

Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-7808 Fax: (714) 730-1310 E-mail: pbiggins@us.medical.canon

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1. MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
1. ESTABLISHMENT REGISTRATION 9614698
1. DATE PREPARED December 2nd, 2020

8. DEVICE NAME

Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

9. TRADE NAME

Vantage Galan 3T, MRT-3020, V7.0 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 Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K192574)

	Subject Device	Predicate Device
System	Vantage Galan 3T, MRT-3020, V7.0 withAiCE Reconstruction Processing Unit for MR	Vantage Galan 3T, MRT-3020, V6.0 withAiCE Reconstruction Processing Unit for MR
Marketed By	Canon Medical Systems USA, Inc.	Canon Medical Systems USA, Inc.
510(k) Number	This Submission	K192574
Clearance Date		March 9, 2020

15. REASON FOR SUBMISSION

Modification of a cleared device

16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

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17. DEVICE DESCRIPTION

18. SUMMARY OF CHANGE(S)

This submission is to report the following software changes:

. FASE 3D/FFE3D:
ം Compressed SPEEDER 3D (Compressed Sensing 3D): This application allows acceleration factors for shorter scan times or higher resolution in FASE3D and FFE3D in addition to FSE2D, imaging based upon the principle of compressed sensing in combination with parallel imaging.
FE 3D: .
ം Fl-Quant: Data is acquired with several different TE and provides PDFF image, R2* image, water image, fat image, in phase image and out of phase image (total 6 kind of images). Proton Density Fat Fraction data and R2* data is supporting fat content ratio.
. EPI
୍ Exsper (Expanded SPEEDER): This application allows reducing scan time for diffusion imaging. Exsper technique scans center of k-space data but surrounding area data is undersampled. It finds the coefficient from the data of center of k-space and synthesize the undersampled data by using surrounding data and the coefficient.
FFE 3D:
- Fast 3D for SSFP: This application allows Fast 3D mode in SSFP 3D sequences, which helps to reduce the scan time by about 50 %.
3D Time-of-Flight (ToF):
- Fast 3D for TOF: This application allows reducing the scan time while maintaining image quality by up to half for TOF images by adjusting data acquisition ratio.
Short T2* map (multi echo-UTE): UTE Imaging is available for acquisition of different TE data for T2* mapping of tissues with short T2*.
Advanced DWI-Diffusion time: Various diffusion times are available
AiCE - noise estimation improvement: By taking into consideration g-factor, noise can be removed from the part where g-factor was considered.

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Made For life

19. SAFETY PARAMETERS

Item	Subject Device:Vantage Galan 3T, MRT-3020, V7.0with AiCE Reconstruction ProcessingUnit for MR	Predicate Device:Vantage Galan 3T, MRT-3020, V6.0with AiCE Reconstruction ProcessingUnit for MR (K192574)	Notes
Static field strength	3T	3T	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 accessrequirements	Allows screen access to 1st leveloperating mode	Allows screen access to 1st leveloperating mode	Same
Maximum SAR	4W/kg for whole body (1st operatingmode specified in IEC 60601-2-33:2010+A1:2013+A2:2015)	4W/kg for whole body (1st operatingmode specified in IEC 60601-2-33:2010+A1:2013+A2:2015)	Same
Maximum dB/dt	1st operating mode specified in IEC60601-2-33:2010+A1:2013+A2:2015	1st operating mode specified in IEC60601-2-33:2010+A1:2013+A2:2015	Same
Potential emergencycondition and meansprovided for shutdown	Shutdown by Emergency Ramp DownUnit for collision hazard forferromagnetic objects	Shutdown by Emergency RampDown Unit for collision hazard forferromagnetic objects	Same

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K192574.

21. INDICATIONS FOR USE

Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces crosssectional 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.

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.

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Image /page/7/Picture/0 description: The image shows the logo for Canon Medical Systems USA, INC. The word "Canon" is in red, and the rest of the text is in black. The text is left-aligned and the font is sans-serif. The logo is simple and professional.

22. SUMMARY OF DESIGN CONTROL ACTIVITIES

Risk Management activities for new software functionalities and pulse sequences 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 Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K192574). A declaration of conformity with design controls is included in this submission.

23. 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 ES60601-1:2005/(R)2012 ● and A1:2012
IEC60601-1-2 (2014)
IEC60601-1-6 (2010), Amd.1 (2013)
IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015)
. IEC60825-1 (2007)
IEC62304 (2006), Amd.1 (2015) ●
IEC62366 (2007), Amd.1 (2014) ●
NEMA MS 1 (2008)
NEMA MS 2 (2008) ●
NEMA MS 3 (2008)
NEMA MS 4 (2010)
NEMA MS 5 (2010)

24. 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.

MR image quality metrics were performed, utilizing volunteer images, to assess 3D FAST sequences and 3D Compressed SPEEDER acceleration sequences. Representative images, reviewed by American Board Certified Radiologists and American Board Certified Cardiologists with MR certification, were obtained using the subject device. Reviewers provided detailed assessments of overall image noise, image sharpness, image degradation, image artifacts, diagnostic contrast, lesion/pathology conspicuity, and clinical utility. It was confirmed that 3D FAST and 3D Compressed SPEEDER 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.

Made For life

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25. SUBSTANTIAL EQUIVALENCE

Canon Medical Systems Corporation believes that the Vantage Galan 3T, MRT-3020, V7.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR is substantially equivalent to the previously cleared predicate device, Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR, referenced in this submission. Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR are substantially equivalent to the previously cleared predicate device.

26. CONCLUSION

The modifications incorporated into the Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR do not change the indications for use or the intended use of the device. Based upon bench testing, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.

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.