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

K220335 · Canon Medical Systems Corporation · LNH · Apr 5, 2022 · Radiology

Device Facts

• Record ID: K220335
• Device Name: Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
• Applicant: Canon Medical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: Apr 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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 Story

1.5T MRI system; utilizes Pianissimo Zen noise reduction; inputs include proton density, T1/T2 relaxation times, flow dynamics, and chemical shift data. System performs cross-sectional imaging (transaxial, coronal, sagittal, oblique). New features include Iterative Motion Correction (IMC) for brain/C-spine to reduce motion artifacts and ceiling camera-based patient orientation/anatomy positioning. Operated by trained professionals in clinical settings. Output is diagnostic MR images interpreted by physicians to aid clinical decision-making. Benefits include improved image quality via motion correction and streamlined patient positioning.

Clinical Evidence

Bench testing only. IMC (Iterative Motion Correction) evaluated using volunteer images to confirm reduction of motion artifacts. Ceiling camera patient orientation and anatomy position detection evaluated using volunteers; success rates met predetermined acceptance criteria.

Technological Characteristics

1.5T MRI system; 1.4m short magnet; 3.8-4.1 ton weight. Pianissimo/Pianissimo Zen noise reduction. XGO or standard gradient systems. Max FOV 55x55cm or 55x50cm. Connectivity: DICOM. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, NEMA MS 1-5. Software: Moderate level of concern.

Indications for Use

Indicated for patients requiring diagnostic MRI imaging of head or body structures; includes non-contrast MRA. No specific age or gender contraindications stated beyond standard MRI safety precautions.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K213305)

Reference Devices

• Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K211633)
• Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K203053)
• Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K202210)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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.

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

## Re: K220335

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: February 3, 2022 Received: February 7, 2022

## Dear Orlando 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

April 5, 2022

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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 ([e-mail]) or phone [phone] 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)

Device Name

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

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

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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 1.5T, MRT-1550, V8.0 with AiCE<br>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

Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: [phone] Fax: [phone] E-mail: [e-mail]

### Official Correspondent/U.S. Agent

Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: [phone] Fax: [phone] E-mail: [e-mail]

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## 5. MANUFACTURING SITE

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

- 6. ESTABLISHMENT REGISTRATION 9614698
- 7. DATE PREPARED

February 2, 2022

## 8. DEVICE NAME

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

### 9. TRADE NAME

Vantage Fortian/Orian 1.5T, 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 (system): Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K213305)

| System | Predicate Device | Reference Device<br>(Previously cleared model) | Reference Device<br>(Previously cleared model) | Reference Device<br>(Previously cleared model) |
|-------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| | Vantage Fortian 1.5T,<br>MRT-1550, V8.0<br>with AiCE Reconstruction<br>Processing Unit for MR | Vantage Orian 1.5T,<br>MRT-1550, V7.0<br>with AiCE Reconstruction<br>Processing Unit for MR | Vantage Orian 1.5T,<br>MRT-1550, V7.0<br>with AiCE Reconstruction<br>Processing Unit for MR | Vantage Orian 1.5T,<br>MRT-1550, V6.0<br>with AiCE Reconstruction<br>Processing Unit for MR |
| Marketed By | Canon Medical Systems USA,<br>Inc. | Canon Medical Systems USA,<br>Inc. | Canon Medical Systems USA,<br>Inc. | Canon Medical Systems<br>USA, Inc. |
| 510(k)<br>Number | K213305 | K211633 | K203053 | K202210 |
| Clearance<br>Date | December 1, 2021 | July 22,<br>2021 | December 2,<br>2020 | September 22,<br>2020 |

## 15. REASON FOR SUBMISSION

Modification of a cleared device

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### 16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

### 17. DEVICE DESCRIPTION

The Vantage Fortian (Model MRT-1550/ WK, WM, WQ, 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 cm and include the standard gradient system.

The Vantage Orian (Model MRT-1550/ UC, 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 MRI System (K213305), cleared December 1, 2021 with the following modifications.

### 18. SUMMARY OF CHANGE(S)

This submission is to report the following changes:

### Summary of Software Changes:

- Iterative Motion Correction (IMC) body region expansion: IMC reduces motion artifact by correcting k-space data based on detecting the amount of motion during scan. Applying IMC in the brain corrects for rigid motion, applying IMC in the C-spine corrects for both rigid and nonrigid motion.
- Exsper Sequence Expansion: Exsper is available in FE2D and SE2D in addition to SE-EPI(DWI) and FSE2D
- . 2D-RMC Sequence Expansion: 2D-RMC is available in FSE2D and FASE2D in addition to FASE3D, FFE3D and SEEPI2D.

## Summary of Accessory Changes:

- Ceiling Camera feature expansion: Patient orientation detection function and Patient anatomy position detection function for projector positioning are added.

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### 19. SAFETY PARAMETERS

| Item | Subject Device:<br>Vantage Fortian/Orian 1.5T,<br>MRT-1550, V8.0 | Predicate Device:<br>Vantage Fortian 1.5T,<br>MRT-1550, V8.0 | 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<br>requirements | Allows screen access to 1st level<br>operating mode | Allows screen access to 1st level<br>operating mode | Same |
| Maximum SAR | 4W/kg for whole body (1st<br>operating mode specified in IEC<br>60601-2-33:<br>2010+A1:2013+A2:2015) | 4W/kg for whole body (1st<br>operating mode specified in IEC<br>60601-2-33:<br>2010+A1:2013+A2:2015) | Same |
| Maximum dB/dt | 1st operating mode specified in IEC<br>60601-2-33:<br>2010+A1:2013+A2:2015 | 1st operating mode specified in IEC<br>60601-2-33:<br>2010+A1:2013+A2:2015 | Same |
| Potential emergency<br>condition and means<br>provided for shutdown | Shutdown by Emergency Ramp<br>Down Unit for collision hazard for<br>ferromagnetic objects | Shutdown by Emergency Ramp<br>Down Unit for collision hazard for<br>ferromagnetic objects | Same |

### 20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K213305.

### 21. INDICATIONS FOR USE

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.

### 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 Fortian 1.5T, MRT-1550, V8.0 (K213305). A declaration of conformity with design controls is included in this submission.

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Image /page/7/Picture/0 description: The image displays the logo for Canon Medical Systems USA, Inc. The word "Canon" is written in a bold, red font, with the rest of the company name appearing in a smaller, black font beneath it. The text is aligned to the left and is set against a white background. The logo is simple and professional, conveying a sense of reliability and expertise.

Made For life

# 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 (2007,2014)
- 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

IMC (Iterative Motion Correction) for head and C-spine was evaluated using volunteer images. Testing confirmed that IMC may reduce motion artifacts.

The patient orientation and patient anatomy position detection method using Ceiling camera function were evaluated using volunteers. It was confirmed that percentage of successful patient orientation detection and cases requiring no correction for successful patient anatomy position detection met 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 1.5T, MRT-1550, V8.0 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Fortian 1.5T, MRT-1550, V8.0, referenced in this submission.

Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 are substantially equivalent to the previously cleared predicate device.

### 26. CONCLUSION

The modifications incorporated into the Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 do not change the indications for use or the intended use of the device. Based on the indications for use, technological characteristics, and safety and performance testing, the subject device meets the requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate device.