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, WQ)/Vantage Orian (Model MRT-1550/ A3, A4, A7, A8) 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 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 gradient system.

The Vantage Orian (Model MRT-1550/ UC, UG, UG, UH, UK, UL, UO, UP, AK, AL, AO, AP, Upgrade only: A3, A4, A7, A8, AC, AD, AG, AH) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian models MRT-1550/ UC, UG, UH, UK, UL, UO, UP, Upgrade only: A3, A4, A7, A8 use 1.4 m short and 4.1 tons light weight magnet while the Vantage Orian models MRT-1550/ AK, AL, AO, AP, Upgrade only: AC, AD, AG, AH use 1.4 m short and 3.8 tons light weight magnet. All of the aforementioned models 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 50 cm. The Model MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP, AK, AL, AO, AP includes the XGO gradient system. The Model MRT-1550/ A3, A4, A7, A8, AC, AD, AG, AH include the standard 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 (K220335), cleared April 5, 2022 with the following modifications.

AI/ML Overview

This FDA 510(k) summary provides limited details regarding the acceptance criteria and the study that proves the device meets those criteria. Here's a breakdown of the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Additionally, image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria." However, it does not explicitly provide a table of these acceptance criteria or the specific reported device performance metrics against them.

The device is a Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR. The submission is a "Modification of a cleared device" (K220335), specifically an update to "Iterative Motion Correction (IMC)" for brain imaging. The primary claim is substantial equivalence to the predicate device.

What is provided:

The summary lists several "Safety Parameters" for the subject device and compares them to the predicate device, indicating they are "Same". These are not "acceptance criteria" for performance but rather safety specifications.

Item	Subject Device: Vantage Fortian/Orian 1.5 T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR	Predicate Device: Vantage Fortian/Orian 1.5 T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K220335)	Notes
Static field strength	1.5T	1.5T	Same
Operational Modes	Normal and 1st Operating Mode	Normal and 1st Operating Mode	Same
Safety parameter display	SAR, dB/dt	SAR, dB/dt	Same
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

The document also states: "Image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria." However, the specific criteria (e.g., Signal-to-Noise Ratio (SNR), Contrast-to-Noise Ratio (CNR), spatial resolution, artifact levels, particularly related to motion artifact reduction for IMC) and the reported performance values against these criteria are not detailed in this summary. The critical aspect of this submission is the improvement in Iterative Motion Correction (IMC) for brain imaging, implying the acceptance criteria would relate to reduced motion artifacts and maintained/improved image quality in the presence of motion.

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

The document mentions "image quality testing" and "bench testing" but does not specify the sample size for the test set used for evaluating the IMC or the overall device performance. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is not provided in the given 510(k) summary. It does not mention any expert reviews for establishing ground truth. Since the modification is related to "Iterative Motion Correction (IMC)" for brain imaging, if expert evaluation was done, it would likely involve radiologists reviewing images for artifact reduction and diagnostic quality.

4. Adjudication Method for the Test Set:

This information is not provided in the given 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

The document does not mention any MRMC study or any assessment of human reader improvement with or without AI assistance. The AiCE (Advanced intelligent Clear-iq Engine) is an AI-based reconstruction processing unit, and the IMC is an update to its functionality. While the device incorporates AI, this submission focuses on demonstrating substantial equivalence and technical performance rather than clinical effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document broadly mentions "image quality testing," "bench testing," and "software validation." These types of tests are typically standalone evaluations of the algorithm's performance. However, specific details about whether this entailed a formal standalone performance study or solely technical verification and validation are not explicitly detailed. Given the technical nature of reconstruction (reducing motion artifacts), standalone performance metrics (e.g., artifact reduction ratios, quantitative image metrics) would be expected.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for image quality testing. For motion correction algorithms, ground truth might involve:
* Simulated motion: Using phantoms or volunteer data with artificially induced and quantifiable motion.
* Expert assessment: Radiologists evaluating images for artifact presence and severity.
* Comparison to "no motion" scans: If available, comparing corrected images to baseline scans without motion.

8. The Sample Size for the Training Set:

This information is not provided in the 510(k) summary. The AiCE is an AI-based reconstruction, meaning it would have been trained on data. This submission describes an "update" to IMC within AiCE, implying the underlying AI model has been refined or retrained.

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

This information is not provided in the 510(k) summary. For AI reconstruction technologies like AiCE, ground truth for training often involves high-quality, artifact-free MRI data, potentially with synthetic degradation to train the model to remove noise and artifacts.

Summary

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October 25, 2022

Canon Medical Systems Corporation % Janine Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, California 92780

Re: K222968

Trade/Device Name: Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 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: September 27, 2022 Received: September 27, 2022

Dear Janine 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.

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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 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 Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K222968

Device Name

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 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)

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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 Fortian/Orian 1.5 T, MRT-1550, V8.0 with AICEReconstruction 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

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

K222968

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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 September 27, 2022

8. DEVICE NAME

Vantage Fortian/Orian 1.5 T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

9. TRADE NAME

Vantage Fortian/Orian 1.5 T, MRT-1550, V8.0 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, V8.0 with AiCE Reconstruction Processing Unit for MR (K220335)

Reference Device: Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR (K222387)

System	Predicate Device	Reference Device
System	Vantage Fortian/Orian 1.5 T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR	Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Marketed By	Canon Medical Systems USA, Inc.	Canon Medical Systems USA, Inc.
510(k) Number	K220335	K222387
Clearance Date	April 5, 2022	August 31, 2022

15. REASON FOR SUBMISSION

Modification of a cleared device

16. SUBMISSION TYPE

Special 510(k) Premarket Notification

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17. DEVICE DESCRIPTION

18. SUMMARY OF CHANGE(S)

This submission is to report the following changes:

Summary of Software Changes:

Iterative Motion Correction (IMC): IMC, as applied to brain imaging, has been updated in order to provide more consistent results in reducing motion artifacts.

19. SAFETY PARAMETERS

ltem	Subject Device:Vantage Fortian/Orian 1.5 T, MRT-1550,V8.0 with AiCE ReconstructionProcessing Unit for MR	Predicate Device:Vantage Fortian/Orian 1.5 T, MRT-1550,V8.0 with AiCE ReconstructionProcessing Unit for MR (K220335)	Notes
Static field strength	1.5T	1.5T	Same
Operational Modes	Normal and 1st Operating Mode	Normal and 1st Operating Mode	Same
i. Safety parameterdisplay	SAR, dB/dt	SAR, dB/dt	Same
ii. Operating modeaccess requirements	Allows screen access to 1st leveloperating mode	Allows screen access to 1st leveloperating mode	Same

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Image /page/6/Picture/0 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is written in red, and the words "CANON MEDICAL SYSTEMS USA, INC." are written in black below the word "Canon". The logo is simple and clean, and it is likely used on the company's website, marketing materials, and products.

Item	Subject Device:	Predicate Device:	Notes
	Vantage Fortian/Orian 1.5 T, MRT-1550,V8.0 with AiCE ReconstructionProcessing Unit for MR	Vantage Fortian/Orian 1.5 T, MRT-1550,V8.0 with AiCE ReconstructionProcessing Unit for MR (K220335)
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 Ramp DownUnit for collision hazard forferromagnetic objects	Same

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K220335.

21. 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 previous predicate submission, K220335.

22. 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 1.5 T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K220335). 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.

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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 logo is simple and clean, and it is likely used on the company's website and marketing materials. The text is left-aligned.

Made For life

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, 2014)
IEC62304 (2006), Amd.1 (2015) ●
IEC62366-1 (2020)
NEMA MS 1 (2008) ●
NEMA MS 2 (2008) ●
NEMA MS 3 (2008) ●
NEMA MS 4 (2010)
NEMA MS 5 (2018)

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.

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.

25. SUBSTANTIAL EQUIVALENCE

Canon Medical Systems Corporation believes that the Vantage Fortian/Orian 1.5 TJ, MRT-1550, V8.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR, is substantially equivalent to the previously cleared predicate device referenced in this submission.

Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Fortian/Orian 1.5 T, MRT-1550, V8.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR, are substantially equivalent to the previously cleared predicate device.

26. CONCLUSION

The modifications incorporated into the Vantage Fortian/Orian 1.5 T, MRT-1550, V8.0, 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 bench testing, 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.