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 Description

The Vantage Galan (Model MRT-3020/A7) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K173382. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Vantage Galan 3T, MRT-3020/A7, V5.0 MRI system.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not present a detailed clinical study with specific acceptance criteria and outcome metrics for diagnostic performance in the way a novel AI-driven diagnostic device might. Instead, it focuses on safety and imaging performance parameters (e.g., field strength, SAR, dB/dt) and software functionalities.

The document states: "No change from the previous predicate submission, K173382." regarding imaging performance parameters. This implies that the device's fundamental imaging quality and diagnostic capability are considered equivalent to the predicate, and therefore, no new studies specifically on diagnostic accuracy for new software features are presented in this summary. The "acceptance criteria" discussed below are thus primarily related to safety, operational limits, and maintaining imaging capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from IEC/NEMA standards & predicate equivalence)	Reported Device Performance (as stated in the document)
Static Field Strength	3T	3T (Same as predicate)
Operational Modes	Normal and 1st Operating Mode (IEC 60601-2-33)	Normal and 1st Operating Mode (Same as predicate)
Safety Parameter Display	SAR, dB/dt	SAR, dB/dt (Same as predicate)
Operating Mode Access	Allows screen access to 1st level operating mode	Allows screen access to 1st level operating mode (Same as predicate)
Maximum SAR	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33: 2010 +A1:2013)	4W/kg for whole body (Same as predicate)
Maximum dB/dt	1st operating mode specified in IEC 60601-2-33: 2010 +A1:2013	1st operating mode specified in IEC 60601-2-33: 2010 +A1:2013 (Same as predicate)
Emergency 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 as predicate)
Imaging Performance	No degradation from predicate (Vantage Galan 3T, MRT-3020, V4.6)	"No change from the previous predicate submission, K173382."
Software Functionality	New functionalities (e.g., KneeLine+, surevol Knee, k-t SPEEDER, R-wave Monitoring, SpineLine+, WFS DIXON, Quick Star, Fast 3D Mode, 2D-RMC for EPI) operate as intended without compromising safety or overall device performance.	Software validation and application of risk management and design controls shown to ensure safety and effectiveness. "Bench testing, phantom imaging, volunteer clinical imaging" were employed.
Indications for Use	Maintain previously cleared indications for use	No changes to the previously cleared indication.

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

The document does not specify a distinct "test set" in the context of a clinical trial for diagnostic performance. The evaluation is primarily focused on engineering and safety verification, implying performance on various physical and phantom tests, alongside some human volunteer imaging.

Sample Size for Test Set: Not explicitly stated. The document mentions "volunteer clinical imaging" but does not quantify the number of volunteers or cases used for demonstrating the performance of the new software features. It is likely that these were smaller-scale internal evaluations.
Data Provenance: Not explicitly stated, but the manufacturing site is Canon Medical Systems Corporation, Japan (1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550). The "volunteer clinical imaging" would likely have occurred within a research setting affiliated with the manufacturer or a collaborating institution. The data would be considered prospective for the purposes of these internal evaluations.

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

This information is not provided in the 510(k) summary. The evaluation focuses on technical performance and safety, rather than providing a detailed diagnostic accuracy study requiring a traditional "ground truth" derived from expert reads. For the "volunteer clinical imaging" and phantom studies, the "ground truth" would be established by technical specifications, established imaging principles, and potentially expert review of image quality by radiologists or MR physicists within the development team, but this is not explicitly documented.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a 510(k) summary for a software update to an MRI system, a formal adjudication process involving multiple readers for diagnostic consensus is not a typical requirement unless there are specific claims about diagnostic accuracy changes which are not made here.

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

No, an MRMC comparative effectiveness study was not done as described in this document. The device is a Magnetic Resonance Diagnostic Device (MRDD) for acquiring and displaying images. While it includes "AI-like" features (e.g., KneeLine+, SpineLine+ for automated plane detection or k-t SPEEDER for image acceleration), these are enhancements to image acquisition and processing, not a traditional "AI" intended for diagnostic interpretation that would involve comparative reader studies against human readers. There are no claims of diagnostic improvement for human readers using this updated software.

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

No, a standalone algorithm performance study as typically understood for an AI diagnostic device was not done or reported. The software features are integrated into the MRI system to improve scan workflow, image quality, and efficiency, not to provide standalone diagnostic interpretations.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of "ground truth" used for clinical evaluation of the software enhancements. However, based on the context of a 510(k) for an MRI system software update, the "ground truth" for evaluating the performance of features like KneeLine+, SpineLine+, or k-t SPEEDER would likely involve:

Technical Specifications / Phantoms: For assessing parameters such as image resolution, signal-to-noise ratio, artifact reduction, and acquisition speed.
Established Anatomical Knowledge / Expert Review of Image Quality: For features like KneeLine+ and SpineLine+, the "ground truth" for auto-detection accuracy would be based on expertly determined anatomical landmarks and planes within the acquired images, reviewed by experienced MR technologists or radiologists for accuracy and consistency against manual methods.
Physiological Measurements: For R-wave monitoring, the ground truth would be from a concurrently acquired ECG signal.

8. The Sample Size for the Training Set

This information is not provided. The document describes software updates and enhanced sequences. While these might employ machine learning algorithms for features like anatomical detection (KneeLine+, SpineLine+), the specific data used for training these algorithms and their sample sizes are not detailed in this 510(k) summary. Given the focus on substantial equivalence, this level of detail is typically not required unless the core diagnostic function is driven by novel AI-learning.

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

This information is not provided. Similar to the training set sample size, the specifics of how ground truth might have been established for any potential machine learning components within the new software features are not disclosed in this regulatory submission.

Summary

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Image /page/0/Picture/0 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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

Canon Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Toshiba America Medical System, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K181593

Trade/Device Name: Vantage Galan 3T, MRT-3020/A7, V5.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 15, 2018 Received: June 18, 2018

Dear Janine Reyes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

August 13, 2018

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

K181593

Device Name

Vantage Galan 3T, MRT-3020/A7, V5.0

Indications for Use (Describe)

·Proton density (PD) (also called hydrogen density) •Spin-lattice relaxation time (T1)

·Spin-spin relaxation time (T2)

·Flow dynamics

•Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K181593

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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 Galan 3T, MRT-3020/A7, V5.0
Model Number:	MRT-3020/A7

2. SUBMITTER'S NAME

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

3. OFFICIAL CORRESPONDENT

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

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

Contact Person

Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 E-mail: jfreyes@us.medical.canon

Official Correspondent/U.S. Agent

Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-7808 Fax: (714) 730-1310 E-mail: pbiggins@us.medical.canon

2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968 https://us.medical.canon

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DICAL SYSTEMS USA, INC.

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1. MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
1. ESTABLISHMENT REGISTRATION 9614698
1. DATE PREPARED June 15th, 2018
1. DEVICE NAME Vantage Galan 3T, MRT-3020/A7, V5.0
1. TRADE NAME

Vantage Galan 3T, MRT-3020/A7, V5.0

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, V4.6

System	Subject	Predicate Device
	Vantage Galan 3T, MRT-3020/A7, V5.0	Vantage Galan 3T, MRT-3020, V4.6
Marketed By	Canon Medical Systems USA, Inc.	Canon Medical Systems USA, Inc.
510(k) Number	This Submission	K173382
Clearance Date		January 26, 2018

15. REASON FOR SUBMISSION

Modification of a cleared device

16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968 https://us.medical.canon

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17. DEVICE DESCRIPTION

18. SUMMARY OF CHANGE(S)

This submission is to report the following software functionalities have been added:

Software change from V4.6 to V5.0 ●
Limited Scan Mode: Operator can set SAR operating mode and upper limit of B1+rms. Scan parameters are calculated so that SAR and B1+rms do not exceed set limits.
KneeLine+: When the basic planes of the knee are to be scanned, this application makes it possible to set the slice plane more easily than before. After a 3D image is acquired, it is used to obtain the three planes (sagittal, axial and coronal) after adjusting the angle of the knee. The obtained images can be used to set the positioning ROI. If necessary, the orientation and position of the detected basic planes can be adjusted by scan positioning operation in the Scan Plan (Locator) window.
surevol Knee: Using a 3D image as an input, the region of the knee is determined and the ● VOI for shimming scan, map scan, or presaturation is detected. The detected VOI can be used for knee scan positioning. If necessary, the VOI can be checked and the orientation and position of the VOI can be adjusted in the Scan Plan (Locator) window.
k-t SPEEDER: Estimated sensitivity data is calculated using the sensitivity data for each coil obtained during scanning, and the folded image obtained by skipped image acquisition is unfolded. A speedup factor of 2 to 8 can be achieved depending on the skipping ratio.
R-wave Monitoring: The range of the R-R intervals for data acquisition can be determined. If the R-R intervals at the time of data acquisition is out of range, data acquisition is performed again.
SpineLine+: New spinal plane detection algorithm improves detection rate for patients.
Sequence Enhancements:
- o WFS DIXON (Water Fat Separation): WFS option previously applicable to FE3D sequences is added to FSE2D sequences.
- o Quick Star: Data acquisition is started from the center of the k-space in a radial pattern in the in-plane direction in the k-space and in a Cartesian pattern in the slice direction. Because the data near the center of the k-space is acquired repeatedly, data acquisition with Quick Star is relatively unaffected by motion.
- oFast 3D Mode: Fast 3D mode can be used to increase imaging efficiency. Two types of Fast 3D mode (Multiple and Wheel) are available. Multiple is technique for acquiring two parallel SE lines continuously in a single shot. Wheel is technique for

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acquiring signals at the center of the k-space in a deformed wheel pattern in the PE-SE plane.

o 2D-RMC (Real-time Motion Correction) for EPI: 2D Real-time Motion Correction is available for Diffusion Weighted Imaging to mitigate respiratory motion artifacts of abdominal examination. 2D-RMC option previously applicable to FASE3D and FFE3D sequences is added to EPI sequences.

19. SAFETY PARAMETERS

Item	Subject Device:Vantage Galan 3T,MRT-3020/A7, V5.0	Predicate Device:Vantage Galan 3T,MRT-3020, V4.6	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 accessrequirements	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)	4W/kg for whole body (1st operatingmode specified in IEC 60601-2-33:2010 +A1:2013)	Same
Maximum dB/dt	1st operating mode specified in IEC60601-2-33: 2010 +A1:2013	1st operating mode specified in IEC60601-2-33: 2010 +A1:2013	Same
Potential emergencycondition and meansprovided for shutdown	Shutdown by Emergency Ramp DownUnit for collision hazard forferromagnetic objects	Shutdown by Emergency RampDown Unit for collision hazard forferromagnetic objects	Same

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K173382.

21. INDICATIONS FOR USE

Proton density (PD) (also called hydrogen density)
Spin-lattice relaxation time (T1)
Spin-spin relaxation time (T2)

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Flow dynamics
. Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

*NOTE: No changes to the previously cleared indication, K173382

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, V4.6 (K173382). 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

IEC60601-1 (2005), Amd.1 (2012)
IEC60601-1-2 (2007)
IEC60601-1-8 (2006), Amd.1 (2012)
IEC60601-2-33 (2010), Amd.1 (2013) ●
IEC60825-1 (2007) ●
IEC62304 (2006)
IEC62366 (2007), Amd.1 (2014) ●
NEMA MS 1 (2008) ●
NEMA MS 2 (2008) ●
NEMA MS 3 (2008) ●
NEMA MS 4 (2010) ●
NEMA MS 5 (2010)

24. TESTING

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/A7, V5.0 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Galan 3T, MRT-3020, V4.6, referenced in this submission. Canon Medical

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Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020/A7, V5.0 are substantially equivalent to the previously cleared predicate device.

26. CONCLUSION

The modifications incorporated into the Vantage Galan 3T, MRT-3020/A7, V5.0 software do not change the indications for use or the intended use of the device. Based upon bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.