Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The predicate device explicitly mentions "AiCE Reconstruction Processing Unit for MR", where AiCE is a known AI-based reconstruction technology from Canon Medical Systems. Additionally, the summary mentions "Mentions AI, DNN, or ML: Yes".

Therapeutic

No
The device is described as a "diagnostic imaging modality" that produces images useful "in diagnosis," rather than for treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is indicated as a "diagnostic imaging modality" and that, when interpreted by a trained physician, the images "yield information that can be useful in diagnosis."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "3 Tesla Magnetic Resonance Imaging (MRI) System," which is a hardware device. While it includes software components for image processing and AI, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the system is a "diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This describes an in vivo imaging system, not a device used to examine specimens derived from the human body in vitro.
Device Description: The device is described as a "3 Tesla Magnetic Resonance Imaging (MRI) System." MRI is an imaging technique performed on a living patient, not on samples in a lab.
Mechanism of Action: The description of how MRI works (spatial distribution of protons, relaxation times, etc.) relates to the physical properties of tissues within the body, not to the analysis of biological samples.
Input Imaging Modality: The input is "Magnetic Resonance Imaging (MRI)," which is an in vivo imaging modality.
Anatomical Site: The anatomical site is "head or body," indicating the device is used on a whole patient.
Performance Studies: The performance studies involve "volunteer images," "phantom images," and "volunteer images," all of which are consistent with evaluating an in vivo imaging system.

IVD devices are specifically designed to perform tests on specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This MRI system does not perform such tests on specimens. It creates images of the internal structures of the body directly.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found'.

Overview

Intended Use / Indications for 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.

Product codes

LNH

Device Description

The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K212056. 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 the head or body.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

MRI

Anatomical Site

Head or body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

sureVOI Liver, LiverLine+, ProstateLine+, and W-SpineLine+ were evaluated using volunteer images. It was confirmed that these features worked as intended, the images were of diagnostic quality, and the test results met predetermined acceptance criteria.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrate that the system requirements have been met.

sureVOI Liver, LiverLine+, ProstateLine+, and W-SpineLine+ were evaluated using volunteer images. It was confirmed that these features worked as intended, the images were of diagnostic quality, and the test results met predetermined acceptance criteria.

Exsper in FSE2D was evaluated utilizing phantom images. It was confirmed that Exsper reduces artifacts caused by unfolding errors, compared to traditional SPEEDER. The functionality testing in FE2D and SE2D was also conducted and it was confirmed that the scanning in those sequences can be conducted without problems.

The functionality testing of 2D-RMC in FSE2D and FASE2D was conducted and it was confirmed that the scanning in those sequences can be conducted without problems.

MR image quality metrics were performed, utilizing phantom images, to assess mART EXP. Testing verified mART EXP can reduce distortion artifacts in the readout direction like mART+ and can also reduce distortion artifacts in the slice direction more than mART+.

IMC (Iterative Motion Correction) for head and C-spine was evaluated using volunteer images. Testing confirmed that IMC is effective in reducing motion artifacts.

RDC DWI was evaluated utilizing phantom images. It was confirmed that the distortion in phase encoding direction was reduced by RDC DWI as compared to conventional images without RDC DWI in SEEPI2D sequence.

pCASL (pseudo-continuous ASL) was evaluated utilizing volunteer images. Testing confirmed CBF values via pCASL met predetermined acceptance criteria.

The patient orientation and patient anatomy position detection method using Celling 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K212056

Reference Device(s)

K213305

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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April 8, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Canon Medical Systems Corporation % Paul Biggins Senior Director Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K220192

Trade/Device Name: Vantage Galan 3T, MRT-3020, 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: January 19, 2022 Received: January 24, 2022

Dear Paul Biggins:

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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Indications for Use

510(k) Number (if known) K220192

Device Name

Vantage Galan 3T, MRT-3020, V8.0 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K220192

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, V8.0 with AiCE 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

Official Correspondent/U.S. Agent

Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (951) 313-7400 Fax: (714) 730-1310 E-mail: pbiggins@us.medical.canon

5. MANUFACTURING SITE

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

6. ESTABLISHMENT REGISTRATION 9614698

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7. DATE PREPARED

January 19, 2022

8. DEVICE NAME

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

9. TRADE NAME

Vantage Galan 3T, MRT-3020, 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 Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K212056)

Reference Device: Vantage Fortian, MRT 1550, V8.0 (K213305)

	Predicate Device	Reference Device
System	Vantage Galan 3T, MRT-3020, V7.0 with AiCE
Reconstruction Processing Unit for MR	Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE
Reconstruction Processing Unit for MR
Marketed By	Canon Medical Systems USA, Inc.	Canon Medical Systems USA, Inc.
510(k) Number	K212056	K213305
Clearance Date	August 4, 2021	December 1, 2021

15. REASON FOR SUBMISSION

Modification of a cleared device

16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

17. DEVICE DESCRIPTION

The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K212056. 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.

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18. SUMMARY OF CHANGE(S)

This submission is to report the following changes:

Summary of Hardware Changes:

Gantry (operation panel)/patient table color change
. Shape Coil and Shape Coil W (K193140)

Summary of Software Changes:

. Artifacts Suppression Techniques:
- mART EXP: mART EXP is 3D method to reduce in-plane and through plane distortion O artifact induced by susceptibility. Each slice is 3D phase-encoded to reduce distortion artifact induced by susceptibility in slice dimension. In addition, this application combines with VAT (View Angle Tilting) method for reducing in-plane distortion artifact induced by susceptibility. In the reconstruction, the data of each slice which is encoded in the slice direction is combined and corrected, and finally the images are registered as 2D multislice images like normal FSE2D. In addition, this application can be used in combination with Compressed SPEEDER application to reduce scan time.
- RDC DWI: RDC DWI is the method to reduce distortion in phase encoding direction for o SEEPI2D sequence. The direction of distortion described above can be reversed by reversing the phase encoding polarity. Hence, the pair of the data that have reversed phase encoding polarity each other is acquired, and then the distortion in reconstructed images can be reduced by estimating displacements between them. In addition, this application can be used in combination with SPEEDER or Exsper.
. pCASL (pseudo-continuous ASL): pCASL is one of the arterial spin labeling (ASL) techniques which can provide perfusion-weighted images without contrast media by subtracting the tag image from the control image. Unlike ASTAR based on pulsed ASL (PASL) technique which asymmetrically applies single tag and control IR pulse on the upper and lower sides of the imaging slab, pCASL uses a train of very short RF pulses with thinner thickness than ASTAR for both tag and control applied upstream of the inflow artery with respect to the imaging slab.
Iterative Motion Correction (IMC): 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 non-rigid motion.
sureVOI Liver: §ਘਾৎ SUREVOI Liver automatically detects liver area and plan scan position for . shimming scan, map scan, axial scan, coronal scan for Real-time Motion Correction (RMC), and VisualPrep scan. The positions of the detected planes can be adjusted using functions provided in the Scan Plan window.
LiverLine+: Machine Learning based detection technology for liver plane. Using 2D images as the input, two kind of MRCP scan plan (MRCP 3D and MRCP 2D) are automatically detected and set for the scan positioning ROIs. The orientations and positions of the detected basic planes can be adjusted using functions provided in the Scan Plan window.
ProstateLine+: Machine Learning based detection technology for prostate plane. Using 3D

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images as the input, five planes (axial, coronal, sagittal, oblique axial, and oblique coronal) of the prostate are automatically detected and set for the scan positioning ROIs. The orientations and positions of the detected planes can be adjusted using functions provided in the Scan Plan window.

. W-SpineLine+: Machine Learning based detection technology for spine plane. Using 3D images of multiple stations covered whole spine region as the input, three planes (sagittal, coronal, and spinal disc planes) conforming to the curvature of the spine are automatically detected and set for the scan positioning ROIs. The orientations and positions of the detected basic planes can be adjusted using functions provided in the Scan Plane window. It is also possible to label to detected spinal discs and can be adjusted using functions provided in the W-SpineLine window.
Exsper Sequence Expansion: Exsper is available in FSE2D, FE2D and SE2D in addition to SE-EPI(DWI)
2D-RMC Sequence Expansion: 2D-RMC is available in FSE2D in addition to FASE3D, FFE3D and SEEPI2D.

Summary of Accessory Changes:

Ceiling Camera: The Ceiling Camera is installed on the ceiling of the scan room and is used for the purpose of assisting patient preparation. The intelligent monitor on the gantry displays the patient view capturing by the ceiling camera and the mid-line of the patient table in real time to assist in patient positioning.
Apps for Tablet UX: The application installed on a tablet allows a preparation of next study and a monitoring of an examination progress. This option allows to install an application for the Tablet UX to tablet from Host PC of the MRI system via web browser on a tablet.

19. SAFETY PARAMETERS

| ltem | Subject Device:
Vantage Galan 3T, MRT-3020, V8.0 | Predicate Device:
Vantage Galan 3T, MRT-3020, V7.0
K212056 | 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
access requirements | Allows screen access to 1st level
operating mode | Allows screen access to 1st level
operating mode | Same |
| Maximum SAR | 4W/kg for whole body (1st operating
mode specified in IEC 60601-2-33:
2010+A1:2013+A2:2015) | 4W/kg for whole body (1st operating
mode specified in IEC 60601-2-33:
2010+A1:2013+A2:2015) | Same |
| Maximum dB/dt | 1st operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015 | 1st operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015 | Same |
| Potential emergency
condition and means
provided for shutdown | Shutdown by Emergency Ramp Down
Unit for collision hazard for
ferromagnetic objects | Shutdown by Emergency Ramp Down
Unit for collision hazard for
ferromagnetic objects | Same |

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20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K212056.

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.

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 Galan 3T, MRT-3020, V7.0 (K203553). 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, 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 (2010) ●

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24. TESTING