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

K211037 · Canon Medical Systems Corporation · LNH · May 17, 2021 · Radiology

Device Facts

• Record ID: K211037
• Device Name: Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
• Applicant: Canon Medical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: May 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

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 •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

Vantage Galan 3T is a 3T MRI system; acquires cross-sectional images of head/body anatomy. Device uses Compressed SPEEDER (2D) parallel imaging technique to accelerate data acquisition; maximum acceleration factor extended to 4.0. System utilizes AiCE (Advanced intelligent Clear-IQ Engine) reconstruction processing unit to transform raw MR signals into diagnostic images. Operated by trained technicians/radiologists in clinical settings. Output images interpreted by physicians to assess proton density, T1/T2 relaxation times, flow dynamics, and chemical shift for diagnostic decision-making. Benefits include reduced scan times while maintaining diagnostic image quality.

Clinical Evidence

Human observer study conducted with 3 board-certified radiologists, 32 studies, and 116 scans. Compared Compressed SPEEDER (2D) acceleration factors of 2.5, 3.0, and 4.0. Results showed no clinically relevant difference in preference between images at 2.5 (predicate) and higher acceleration factors. All images were diagnostic, demonstrating equivalent performance to the predicate.

Technological Characteristics

3T MRI system; utilizes Compressed SPEEDER (2D) parallel imaging and AiCE reconstruction. Operates in Normal and 1st Operating Modes per IEC 60601-2-33. Safety parameters (SAR, dB/dt) remain unchanged. System includes emergency ramp-down unit for ferromagnetic collision hazards. Software/hardware architecture is identical to K203323.

Indications for Use

Indicated for diagnostic imaging of head or body anatomy in patients requiring cross-sectional transaxial, coronal, sagittal, or oblique MRI, including non-contrast MRA. No specific age or gender contraindications provided.

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 Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K203323)

Submission Summary (Full Text)

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Image /page/0/Picture/10 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 % Ms. Janine Reyes Manager, Regulatory Affairs Canon Medical Systems USA, INC. 2441 Michelle Drive TUSTIN CA 92780

### Re: K211037

Trade/Device Name: Vantage Galan 3T, MRT-3020, V6.0 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: April 5, 2021 Received: April 7, 2021

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

May 17, 2021

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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 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 ([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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K211037

Device Name

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

Indications for Use (Describe)

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

•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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/3 description: The image shows the logo for Canon Medical Systems USA, INC. The word "Canon" is written in red, while the rest of the text is in black. The text is left-aligned and appears to be professionally designed. The logo is simple and clean, with a focus on the company name.

Made For life

### 510(k) SUMMARY

K211037

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, V6.0 with AiCE<br>Reconstruction Processing 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: [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]

2441 Michelle Drive, Tustin, CA 92780 PHONE: [phone] https://us.medical.canon

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# ICAL SYSTEMS USA, INC.

Made For life

- 5. MANUFACTURING SITE
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

- 6. ESTABLISHMENT REGISTRATION 9614698
## 7. DATE PREPARED

April 5th, 2021

#### 8. DEVICE NAME

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

#### 9. TRADE NAME

Vantage Galan 3T, MRT-3020, V6.0 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 Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K203323)

#### TABLE No. 1: Predicate Device

| | Subject Device | Predicate Device |
|----------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| System | Vantage Galan 3T, MRT-3020, V6.0 with<br>AiCE Reconstruction Processing Unit for MR | Vantage Galan 3T, MRT-3020, V6.0 with<br>AiCE Reconstruction Processing Unit for MR |
| Marketed By | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. |
| 510(k) Number | This Submission | K203323 |
| Clearance Date | | March 4th, 2021 |

#### 15. REASON FOR SUBMISSION

Extension of the Compressed SPEEDER (2D) maximum acceleration factor of up to 4 with no changes to the cleared software and hardware.

²⁴⁴¹ Michelle Drive, Tustin, CA 92780 PHONE: [phone] https://us.medical.canon

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## CAL SYSTEMS USA, INC.

*Made For life*

#### 16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

#### 17. DEVICE DESCRIPTION

The Vantage Galan (Model MRT-30200) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K203323. 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.

#### 18. SUMMARY OF CHANGE(S)

Extension of the Compressed SPEEDER (2D) maximum acceleration factor:

| Subject Device | Predicate Device (K203323) |
|----------------|----------------------------|
| Up to 4 | Up to 2.5 |

#### 19. SAFETY PARAMETERS (unchanged)

| Item | Subject Device:<br>Vantage Galan 3T, MRT-3020, V6.0,<br>with AiCE Reconstruction Processing<br>Unit for MR | Predicate Device:<br>Vantage Galan 3T, MRT-3020, V6.0,<br>with AiCE Reconstruction Processing<br>Unit for MR (K203323) | Notes |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------|
| Static field strength | 3T | 3T | Same |
| Operational Modes | Normal and 1st Operating Mode | Normal and 1st Operating Mode | Same |
| i. Safety parameter<br>display | SAR, dB/dt | SAR, dB/dt | Same |
| ii. Operating mode<br>access 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 operating<br>mode specified in IEC 60601-2-33:<br>2010+A1:2013+A2:2015) | 4W/kg for whole body (1st operating<br>mode specified in IEC 60601-2-33:<br>2010+A1:2013+A2:2015) | Same |
| Maximum dB/dt | 1st operating mode specified in IEC<br>60601-2-33: 2010+A1:2013+A2:2015 | 1st operating mode specified in IEC<br>60601-2-33: 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 Down<br>Unit for collision hazard for<br>ferromagnetic objects | Same |

#### 20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K203323.

#### 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.

2441 Michelle Drive, Tustin, CA 92780 PHONE: [phone] https://us.medical.canon

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Image /page/6/Picture/3 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is in large, bold, red letters. Below it, in smaller, black letters, is the text "CANON MEDICAL SYSTEMS USA, INC."

*Made For life*

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

No change from the previous predicate submission, K203323. 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 submission is a modification that extends the maximum acceleration factor of Compressed SPEEDER (2D). There are no changes to the software and hardware from the previous Pre-Market Notification 510(k) K203323.

#### 24. TESTING

Human observer study of Compressed SPEEDER (2D) with acceleration factors of 2.5, 3.0 and 4.0 was conducted with three board certified radiologists per anatomy, thirty two studies, and one hundred and sixteen scans that demonstrated no clinically-relevant difference in preference between the predicate Compressed SPEEDER (2D) images with acceleration factor of 2.5 when compared to the higher acceleration factor (shorter scan time) images. The results of the testing demonstrated that Compressed SPEEDER (2D) with the acceleration factors of 2.5, 3.0 and 4.0 performed at the equivalent performance level to the commercially available predicate device and all images with each acceleration factor are diagnostic.

#### 25. SUBSTANTIAL EQUIVALENCE

Canon Medical Systems Corporation believes that the Vantage Galan 3T, MRT-3020, V6.0, 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, as there is no change to the hardware and software of the predicate device. Additionally, the testing conducted demonstrates that the device performance is equivalent to the predicate device for the Compressed SPEEDER (2D) acceleration factors that are stated above.

#### 26. CONCLUSION

The Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR does not have any change for the indications for use or the intended use of the device. Bench testing and volunteer clinical imaging additionally conducted does not change the conclusion that the subject device is safe and effective for its intended use.