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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR. This submission primarily focuses on software and accessory changes to an already cleared device. Due to the nature of a 510(k) summary, detailed acceptance criteria and in-depth study results are not fully elaborated in the provided document, as it emphasizes substantial equivalence to a predicate device.

However, I can extract the information that is present and highlight what is not explicitly detailed, based on the structure of your request.

Here's a breakdown of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "the test results met predetermined acceptance criteria" for various features. However, it does not provide a specific table or quantified acceptance criteria values, nor does it give specific numerical performance metrics for these criteria. The performance is described qualitatively.

Feature/Functionality	Acceptance Criteria (Not Quantified)	Reported Device Performance (Qualitative)
sureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+	"worked as intended", "images were of diagnostic quality", "test results met predetermined acceptance criteria"	Confirmed that these features worked as intended, the images were of diagnostic quality.
Exsper in FSE2D	"reduces artifacts caused by unfolding errors, compared to traditional SPEEDER"	Confirmed that Exsper reduces artifacts caused by unfolding errors, compared to traditional SPEEDER. Functionality testing in FE2D and SE2D confirmed scanning without problems.
2D-RMC in FSE2D and FASE2D	"scanning... can be conducted without problems"	Confirmed that the scanning in those sequences can be conducted without problems.
mART EXP	"reduce distortion artifacts"	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)	"effective in reducing motion artifacts"	Testing confirmed that IMC is effective in reducing motion artifacts for head (rigid motion) and C-spine (rigid and non-rigid motion).
RDC DWI	"distortion... reduced"	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)	"CBF values... met predetermined acceptance criteria"	Testing confirmed CBF values via pCASL met predetermined acceptance criteria.
Ceiling Camera	"percentage of successful patient orientation detection and cases requiring no correction for successful patient anatomy position detection met predetermined acceptance criteria"	Confirmed that percentage of successful patient orientation detection and cases requiring no correction for successful patient anatomy position detection met predetermined acceptance criteria. These percentages are not specified.

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

Sample Sizes: The document states that "sureVOI Liver, LiverLine+, ProstateLine+, and W-SpineLine+ were evaluated using volunteer images," "IMC (Iterative Motion Correction) for head and C-spine was evaluated using volunteer images," and "pCASL (pseudo-continuous ASL) was evaluated utilizing volunteer images." The Ceiling Camera function was evaluated using volunteers. No specific number of volunteers or images is provided. Phantom images were used for Exsper and RDC DWI.
Data Provenance: The document implies these studies were conducted by Canon Medical Systems Corporation in Japan, as it lists their manufacturing site and official correspondent there. The patient data origin (country) is not specified. It can be inferred that the data is prospective given the use of "volunteer images" for testing certain features.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test sets. It mentions that images are "interpreted by a trained physician" as part of the overall indications for use, but this is a general statement, not specific to the validation study.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (such as 2+1, 3+1, or none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance, nor does it specify an effect size for such a study. The functionalities described are primarily about improving image quality, reducing artifacts, or automating scan planning, rather than direct diagnostic AI assistance for human readers in a comparative effectiveness study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document describes several software features that perform automated tasks (e.g., sureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+ for auto-detection and scan planning; IMC, RDC DWI, Exsper for image reconstruction/artifact reduction). These functions effectively demonstrate "algorithm-only" performance in their specific tasks without explicit human-in-the-loop evaluation being described in the validation section. For instance, the acceptance of automatic detection and planning functions implies a standalone evaluation of the algorithm's ability to identify relevant anatomical regions.

7. The Type of Ground Truth Used

The document implies the following types of ground truth:

For automated scan planning features (sureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+): The ground truth seems to be derived from expert-confirmed correct anatomic localization and scan planning, as the outcome measure is whether the features "worked as intended" and "images were of diagnostic quality." This implicitly means agreement with human-expert derived optimal scan planes.
For image quality/artifact reduction features (Exsper, mART EXP, IMC, RDC DWI): The ground truth relates to the absence or reduction of artifacts and the diagnostic quality of the resulting images. This would likely be assessed by expert review and comparison to images without the feature, or a recognized "ground truth" image.
For pCASL: "CBF values via pCASL met predetermined acceptance criteria." This suggests a quantitative ground truth for Cerebral Blood Flow (CBF) values, possibly established through established methods or phantom measurements.
For Ceiling Camera: "percentage of successful patient orientation detection and cases requiring no correction for successful patient anatomy position detection met predetermined acceptance criteria." This suggests a ground truth for correct patient orientation and anatomy position, likely established by human observation or measurement.

8. The Sample Size for the Training Set

The document does not provide specific details about the sample size used for the training set (if any) for the machine learning-based features (LiverLine+, ProstateLine+, W-SpineLine+). As this is a 510(k) for a modification, the focus is on validation of the changes rather than a full de novo submission of an AI algorithm, so training data details are often omitted if not directly relevant to the new functionality's validation.

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

The document does not provide details on how ground truth was established for any training data used for the machine learning-based features.

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.

·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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Image /page/3/Picture/0 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is written in red, with the rest of the company name in black. The text is left-aligned and appears to be a standard corporate logo.

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 ReconstructionProcessing Unit for MR
Model Number:	MRT-3020

2. SUBMITTER'S NAME

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

3. OFFICIAL CORRESPONDENT

Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance Canon Medical Systems Corporation

4. CONTACT PERSON, U.S. AGENT and ADDRESS

Contact Person

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 AiCEReconstruction Processing Unit for MR	Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCEReconstruction 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

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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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AL SYSTEMS USA, INC.

Made For life

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, V7.0K212056	Notes
Static field strength	3T	3T	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
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

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20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K212056.

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.

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

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.

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 Galan 3T, MRT-3020, V8.0 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Galan 3T, MRT-3020, V7.0, referenced in this submission.

Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020, V8.0 are substantially equivalent to the previously cleared predicate device.

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26. CONCLUSION

The modifications incorporated into the Vantage Galan 3T, MRT-3020, 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.

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.