Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.

Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.

The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters and must be controlled and validated by the clinical user.

In addition, the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.

Device Description

The proposed MR 5300 and MR 7700 R11 MR Systems are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices, hereafter to be known as MR 5300 and MR 7700 MR Systems.

This Special 510(k) submission will include modifications of the proposed MR 5300 and MR 7700 R11 MR Systems as compared to our legally marketed devices, primary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 05/16/2022) and the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021).

The proposed MR 5300 and MR 7700 MR systems will be brought up to the new baseline software R11. This R11 software is cleared on the Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in the following primary predicate 510(k) Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). Both the proposed MR 5300 and MR 7700 MR systems are already cleared with the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021).

AI/ML Overview

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The verification and/or validation test results demonstrate that the proposed MR 5300 and MR 7700 R11 MR Systems meet the acceptance criteria and are adequate for the intended use." and "The results of these tests demonstrate that the proposed MR 5300 and MR 7700 R11 MR Systems meet the acceptance criteria and are adequate for the intended use."

However, the provided text does not explicitly list specific acceptance criteria in a tabular format, nor does it quantify specific performance metrics for the device against such criteria. Instead, it refers to broad compliance with standards and successful completion of verification/validation tests. The device's performance is implicitly stated as "meeting the acceptance criteria" of these tests and compliance with recognized standards.

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

The document broadly mentions "Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results."

However, the text does not provide any details about the sample size (e.g., number of cases, number of images) used for these non-clinical verification and validation tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) of any data used in these tests.

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

The document makes no mention of experts being used to establish ground truth for a test set. The validation primarily focuses on technical compliance and functional verification against internal specifications and external standards.

4. Adjudication Method for the Test Set:

No information is provided regarding an adjudication method. This is consistent with the lack of expert involvement in establishing ground truth for a test set described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document explicitly states: "The proposed Ingenia MR 5300 and MR 7700 R11 MR Systems did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."

Therefore, no MRMC comparative effectiveness study was done, and consequently, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The device is an MR System, a diagnostic imaging device. The various software enhancements (e.g., SmartSpeed AI, SmartSpeed MotionFree) listed are features of the MR system. The evaluation appears to be of the integrated system's technical and safety compliance rather than a standalone algorithm with distinct performance metrics evaluated without human intervention. The provided text does not describe a standalone algorithm-only performance study.

7. Type of Ground Truth Used:

Given that the document describes "Non-Clinical verification and or validation tests" and mentions compliance with "technical claims, the requirement specifications and the risk management results," the "ground truth" for the tests appears to be technical specifications, functional requirements, and established industry standards rather than expert consensus on medical images, pathology results, or outcomes data. The clearance is based on substantial equivalence to predicate devices demonstrated through these non-clinical tests.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is consistent with the nature of the submission, which focuses on hardware and software enhancements to existing medical devices rather than the development and validation of a new AI model requiring a separate training dataset. The AI functions mentioned (SmartSpeed AI) are integrated into the system, and their validation is part of the overall system's non-clinical testing.

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

As no training set is described, no information is provided on how ground truth for a training set was established.

Summary

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December 23, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name reads "U.S. Food & Drug Administration".

Philips Medical Systems Nederlands B.V. % Susan Quick Regulatory Affairs Manager Veenpluis 6 Best. 5684 PC NETHERLANDS

Re: K223442

Trade/Device Name: MR 5300 and MR 7700 R11 MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI Dated: November 14, 2022 Received: November 14, 2022

Dear Susan Quick:

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,

Z. H. Ke

Laurel Burk, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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)

K223442

Device Name MR 5300 and MR 7700 R11 MR Systems

Indications for Use (Describe)

The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cvcle.

The systems can use combinations of images to produce physical parameters, and related derived images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user.

In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities.

MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with NR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.

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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Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging Special 510(k)

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	Nov. 14, 2022
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277
Primary Contact Person:	Susan QuickRegulatory Affairs ManagerTelephone: (440) 869-4612E-mail: susan.quick@philips.com
Secondary Contact Person	Jan van de KerkhofAssociate Director Regulatory AffairsTelephone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com
Device Name:	MR 5300 and MR 7700 R11 MR Systems
Classification:	Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Regulation: 21CFR 892.1000Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: 90LNH90LNI
Primary Predicate Device:	Trade name: Achieva, Ingenia, Ingneia CX, Ingenia Elition, And Ingenia Ambition MR Systems R11Manufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K213583Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice class: Class IIProduct Code: 90LNH90LNI
Secondary Predicate Device:	Trade name: Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi NucleiManufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K213516
	ClassificationRegulation:	21CFR 892.1000
	Classification name:	Magnetic Resonance Diagnostic Device(MRDD)
	Classification Panel:	Radiology
	Device class	Class II
	Product Code:	90LNH90LNI
SecondaryPredicate Device:	Trade name:	MR 5300
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) Clearance:	K212673
	ClassificationRegulation:	21CFR 892.1000
	Classification name:	Magnetic Resonance Diagnostic Device(MRDD)
	Classification Panel:	Radiology
	Device class	Class II
	Product Code:	90LNH90LNI

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Device	Description:	The proposed MR 5300 and MR 7700 R11 MR Systems are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices, hereafter to be known as MR 5300 and MR 7700 MR Systems.
		This Special 510(k) submission will include modifications of the proposed MR 5300 and MR 7700 R11 MR Systems as compared to our legally marketed devices, primary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 05/16/2022) and the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021).
		The proposed MR 5300 and MR 7700 MR systems will be brought up to the new baseline software R11. This R11 software is cleared on the Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in the following primary predicate 510(k) Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). Both the proposed MR 5300 and MR 7700 MR systems are already cleared with the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021).
Indications forUse:	In this 510(k) submission, Philips Medical Systems Nederland B.V. willbe addressing the following minor software enhancements to theproposed MR 5300 and MR 7700 R11 MR Systems when comparedto the legally marketed primary predicate, Achieva, Ingenia, IngeniaCX, Ingenia Elition and Ingenia Ambition MR Systems R11(K213583, 05/16/2022) and the secondary predicate devices Ingenia3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 withdistributed Multi Nuclei (K213516, 03/03/2022) and MR 5300(K212673, 11/19/2021) :
	1. SmartSpeed AI2. SmartSpeed MotionFree3. SmartSpeed 3D FreeBreathing4. SmartSpeed Implant5. SmartSpeed DWI6. MR Workspace7. ISP MR Packages8. MR Elastography (MR 5300 only)
	This 510(k) submission will also address the following minor hardwareenhancements:
	1. Introduction of a graphical processing unit in the host reconcomputer for image reconstruction2. Additional monitor as part of the operating console
	The supporting documentation provided for the proposed MR 5300 andMR 7700 R11 MR Systems , includes software and hardwaremodifications that are addressed in test reports for system leveldevelopment project, Voyager R11.1.
	The proposed MR 5300 and MR 7700 R11 MR Systems are intendedto be marketed with the following pulse sequences and coils that arepreviously cleared by FDA:
	1. mDIXON (K102344)2. SWIp (K131241)3. mDIXON-Quant (K133526)4. MRE (K140666)5. mDIXON XD (K143128)6. O-MAR (K143253)7. 3D APT (K172920)8. Compatible System Coils
	There are no changes to the indications for use statement, providedbelow, of the proposed MR 5300 and MR 7700 R11 MR Systemswhen compared to the primary predicate Achieva, Ingenia, Ingenia CX,Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583,05/16/2022) .
	Philips Magnetic Resonance (MR) systems are Medical ElectricalSystems indicated for use as a diagnostic device.
	This MR system enables trained physicians to obtain cross-sectionalimages, spectroscopic images and/or spectra of the internal structureof the head, body or extremities, in any orientation, representing thespatial distribution of protons or other nuclei with spin.
	Image appearance is determined by many different physical propertiesof the tissue and the anatomy, the MR scan technique applied, andpresence of contrast agents.
	The use of contrast agents for diagnostic imaging applications shouldbe performed consistent with the approved labeling for the contrastagent.
	The trained clinical user can adjust the MR scan parameters tocustomize image appearance, accelerate image acquisition, andsynchronize with the patient's breathing or cardiac cycle. The systemscan use combinations of images to produce physical parameters, andrelated derived images. Images, spectra, and measurements ofphysical parameters, when interpreted by a trained physician, provideinformation that may assist diagnosis and therapy planning. Theaccuracy of determined physical parameters depends on system andscan parameters and must be controlled and validated by the clinicaluser.
	In addition, the Philips MR systems provide imaging capabilities, suchas MR fluoroscopy, to guide and evaluate interventional and minimallyinvasive procedures in the head, body and extremities. MRInterventional procedures, performed inside or adjacent to the PhilipsMR system, must be performed with MR Conditional or MR Safeinstrumentation as selected and evaluated by the clinical user for usewith the specific MR system configuration in the hospital. Theappropriateness and use of information from a Philips MR system for aspecific interventional procedure and specific MR system configurationmust be validated by the clinical user.
Design Features/FundamentalScientificTechnology:	The proposed MR 5300 and MR 7700 R11 MR Systems are based onthe principle that certain atomic nuclei present in the human body willemit a weak relaxation signal when placed in a strong magnetic fieldand excited by a radio signal at the precession frequency. The emittedrelaxation signals are analyzed by the system and a computed imagereconstruction is displayed on a video screen.
	The principal technological components (magnet, transmit body coil,gradient coil, gradient amplifier, RF amplifier and patient support) of theproposed MR 5300 and MR 7700 R11 MR Systems are identical tothose used in the legally marketed primary predicate, Achieva,Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MRSystems R11 (K213583, 05/16/2022) and the secondary predicatedevices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700
	with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300(K212673, 11/19/2021).
	The software R11 used on the proposed MR 5300 and MR 7700 R11MR Systems is previously cleared on the legally marketed primarypredicate, Achieva, Ingenia, Ingenia CX, Ingenia Elition and IngeniaAmbition MR Systems R11 (K213583, 05/16/2022).
Summary of Non-ClinicalPerformance Data:	The proposed MR 5300 and MR 7700 R11 MR Systems are incompliance with the following international and FDA-recognizedconsensus standards:• IEC60601-1 Edition 3• IEC60601-1-2 Edition 4• IEC60601-1-6 Edition 3• IEC62366-1 Edition 1• IEC60601-1-8 Edition 2• IEC60601-2-33 Edition 3• IEC 62304 Edition 1• NEMA MS-1 2008• NEMA MS-4 2010• NEMA MS-8 2008• NEMA PS 3.1-PS 3.20• ISO 14971 Edition 2• Device specific guidance document, entitled "Guidance for theSubmission Of Premarket Notifications for Magnetic ResonanceDiagnostic Devices" (issued November 18, 2016 – documentnumber 340)• Guidance for Industry and FDA Staff – Guidance for theContent of Premarket Submissions for Software Contained inMedical Devices (issued May 11, 2005 – document number337)• Guidance for Industry and FDA Staff – Content of PremarketSubmissions for Management of Cybersecurity in MedicalDevices (issued October 2, 2014 – document number 1825)• Guidance for Industry and FDA Staff – Applying Human Factorsand Usability Engineering to Medical Devices (issued February3, 2016 – document number 1757)• Guidance for Industry and FDA Staff – Use of InternationalStandard ISO 10993-1, “Biological evaluation of medicaldevices - Part 1: Evaluation and testing within a riskmanagement process" (issued June 16, 2016 – documentnumber 1811)• Guidance for Industry and FDA Staff – Information to Support aClaim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016 – documentnumber 1400057)• Guidance for Industry and FDA Staff – Design Considerationsand Premarket Submission Recommendations for InteroperableMedical Devices (issued September 6, 2017 – documentnumber 1500015)

	Non-Clinical verification and or validation tests have been performedwith regards to the intended use, the technical claims, the requirementspecifications and the risk management results.
	The verification and/or validation test results demonstrate that theproposed MR 5300 and MR 7700 R11 MR Systems meet theacceptance criteria and are adequate for the intended use.
	Additionally, the risk management activities show that all risks aresufficiently mitigated; that new risks that were identified are mitigated toan acceptable level; and that the overall residual risk is acceptable.
	Therefore, the proposed MR 5300 and MR 7700 R11 MR Systems aresubstantially equivalent to the legally marketed primary predicate,Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia AmbitionMR Systems R11 (K213583, 05/16/2022) and the secondary predicatedevices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300(K212673, 11/19/2021), in terms of safety and effectiveness.
Summary ofClinical Data:	The proposed Ingenia MR 5300 and MR 7700 R11 MR Systems didnot require a clinical study since substantial equivalence to the legallymarketed predicate device was proven with the verification/validationtesting.
SubstantialEquivalence:	The proposed MR 5300 and MR 7700 R11 MR Systems and thelegally marketed primary predicate, Achieva, Ingenia, Ingenia CX,Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583,05/16/2022) and the secondary predicate devices Ingenia 3.0T,Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributedMulti Nuclei (K213516, 03/03/2022) and MR 5300 (K212673,11/19/2021) have the same indications for use with respect to thefollowing:Providing cross-sectional images based on the magneticresonance phenomenon Interpretation of the images is the responsibility of trainedphysicians Images can be used for interventional and treatment planningpurposes
Conclusion:	The proposed MR 5300 and MR 7700 R11 MR Systems aresubstantially equivalent to the legally marketed primary predicatedevice, Achieva, Ingenia, Ingenia CX, Ingenia Elition and IngeniaAmbition MR Systems R11 (K213583, 05/16/2022) and thesecondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, IngeniaElition, and MR 7700 with distributed Multi Nuclei (K213516,03/03/2022) and MR 5300 (K212673, 11/19/2021), in terms of designfeatures, fundamental scientific technology, indications for use, andsafety and effectiveness.Additionally, substantial equivalence is demonstrated with non-clinicalperformance (verification and validation) tests, which complied with the

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requirements specified in the international and FDA-recognized consensus standards and device-specific guidance.
The results of these tests demonstrate that the proposed MR 5300 and MR 7700 R11 MR Systems meet the acceptance criteria and are adequate for the 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.