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 MR scan technique applied, and presence of contrast agents. The use of contrast 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, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assust 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

This Special 510(k) submission will include modifications of the proposed Ingenia Elition and MR 7700 MR Systems as compared to Philips legally marketed devices, primary predicate device MR 7700 R11 MR System of the 510(k) submission MR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) as well as the secondary predicate device being the legally marketed Ingenia Elition R11 MR System of the 510(k) submission Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following minor hardware enhancements for the proposed Ingenia Elition and MR 7700 MR Systems since the last 510(k) submission (K223442, 12/23/2022) for each of the systems: 1. The SmokeDetector Interlock, a component used in the legally marketed Ingenia Elition and MR 7700 systems, becomes a mandatory risk control measure. 2. Minor design change to current gradient coil type WB30S Identical to the predicate devices, the proposed Ingenia Elition and MR 7700 MR Systems are intended to be marketed with the following pulse sequences and coils that are previously 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 (identical to the predicate devices)

AI/ML Overview

The provided FDA 510(k) summary for the Philips Ingenia Elition and MR 7700 MR Systems does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/human-in-the-loop study. Instead, this submission is for minor hardware enhancements and focuses on demonstrating substantial equivalence to previously cleared predicate devices through compliance with recognized standards and non-clinical verification tests.

Therefore, I cannot provide details for most of the requested information points, as they are not present in the given text. The submission explicitly states: "The proposed Ingenia Elition and MR 7700 MR Systems did not introduce any modification to the indication for use or technological characteristics relative to the predicate devices that would require clinical testing."

However, I can extract information related to the non-clinical performance data and the general approach.

Here's the breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Compliance with IEC 60601-2-33 (Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis)	Verification test results demonstrate that the proposed Ingenia Elition and MR 7700 MR Systems meet the acceptance criteria and are adequate for the intended use.
Compliance with ANSI/AAMI ES60601-1 (Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance)	Verification test results demonstrate that the proposed Ingenia Elition and MR 7700 MR Systems meet the acceptance criteria and are adequate for the intended use.
Compliance with IEC 60601-1-2 (Electromagnetic disturbances Requirements and tests)	Verification test results demonstrate that the proposed Ingenia Elition and MR 7700 MR Systems meet the acceptance criteria and are adequate for the intended use.
Compliance with IEC 60601-1-6 (Usability)	Verification test results demonstrate that the proposed Ingenia Elition and MR 7700 MR Systems meet the acceptance criteria and are adequate for the intended use.
Compliance with IEC 60601-1-8 (Alarm systems)	Verification test results demonstrate that the proposed Ingenia Elition and MR 7700 MR Systems meet the acceptance criteria and are adequate for the intended use.
Compliance with ISO 14971 (Application of risk management to medical devices)	Risk management activities show that all risks are sufficiently mitigated; new risks identified are mitigated to an acceptable level; and overall residual risk is acceptable.
Compliance with IEC 62366-1 (Application of usability engineering to medical devices)	Verification test results demonstrate that the proposed Ingenia Elition and MR 7700 MR Systems meet the acceptance criteria and are adequate for the intended use.
Compliance with IEC 62304 (Medical device software - Software life cycle processes)	Verification test results demonstrate that the proposed Ingenia Elition and MR 7700 MR Systems meet the acceptance criteria and are adequate for the intended use.
No significant changes to the essential performance and safety of the device compared to predicate.	Non-clinical verification tests performed with regards to requirement specifications and risk management demonstrate the device meets acceptance criteria and is adequate for intended use. Validation testing performed with primary and secondary predicate devices remains valid.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The submission focuses on non-clinical verification tests against standards for hardware modifications, not performance on a specific dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/provided. No clinical study involving expert ground truth is described. The assessment is based on engineering verification and compliance with standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/provided. No clinical study is described.

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, not done. This submission is for minor hardware enhancements to an MR system, not for an AI-powered diagnostic aid, and therefore, no MRMC study or AI assistance evaluation is mentioned.

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

No, not done. As mentioned, this is not an AI-powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/provided. For the purpose of this submission, the "ground truth" for the device's acceptable performance is defined by compliance with established international and FDA-recognized consensus standards for medical electrical equipment and risk management.

8. The sample size for the training set

Not applicable/provided. There is no mention of a training set as this is not an AI/machine learning device submission.

9. How the ground truth for the training set was established

Not applicable/provided. There is no mention of a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 28, 2023

Philips Medical Systems, Nederland B.V. % Ioana Ulea Senior Regulatory Affairs Specialist Veenpluis 4-6 Best. 5684 PC Netherlands

Re: K230972

Trade/Device Name: Ingenia Elition and MR 7700 MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: April 5, 2023 Received: April 5, 2023

Dear Ioana Ulea:

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

{1}------------------------------------------------

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 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,

D. Kyle Kramer

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230972

Device Name

Ingenia Elition and MR 7700 MR Systems

Indications for Use (Describe)

Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied, and presence of contrast agents. The use of contrast 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, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assust 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.

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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue letters, making the word easily readable.

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:	April. 05, 2023
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277
Primary Contact Person:	Ioana UleaSenior Regulatory Affairs SpecialistPhone: +31 618345875E-mail: ioana.ulea@philips.com
Secondary Contact Person	Jan van de KerkhofAssociate Director Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com
Device Name:	Ingenia Elition and MR 7700 MR Systems
Classification:	Classification name: Magnetic Resonance Diagnostic Device (MRDD)
	Classification Regulation: 21CFR 892.1000
	Classification Panel: Radiology
	Device Class: Class II
	Primary Product Code: 90LNH90LNI
Primary Predicate Device:	Trade name: MR 5300 and MR 7700 R11 MR Systems
	Manufacturer: Philips Medical Systems Nederland B.V.
	510(k) Clearance: K223442
	Classification Regulation: 21CFR 892.1000
	Classification name: Magnetic Resonance Diagnostic Device (MRDD)
	Classification Panel: RadiologyDevice class: Class IIProduct Code: 90LNH90LNI
Secondary Predicate Device:	Trade name: Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11
	Manufacturer: Philips Medical Systems Nederland B.V.
	510(k) Clearance: K213583
	Classification Regulation: 21CFR 892.1000
Classification name:	Magnetic Resonance Diagnostic Device(MRDD)
Classification Panel:	Radiology
Device class	Class II
Product Code:	90LNH90LNI

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. The word is horizontally oriented and centered in the image.

Device Description:	This Special 510(k) submission will include modifications of the proposed Ingenia Elition and MR 7700 MR Systems as compared to Philips legally marketed devices, primary predicate device MR 7700 R11 MR System of the 510(k) submission MR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) as well as the secondary predicate device being the legally marketed Ingenia Elition R11 MR System of the 510(k) submission Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022).In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following minor hardware enhancements for the proposed Ingenia Elition and MR 7700 MR Systems since the last 510(k) submission (K223442, 12/23/2022) for each of the systems:1. The SmokeDetector Interlock, a component used in the legally marketed Ingenia Elition and MR 7700 systems, becomes a mandatory risk control measure.2. Minor design change to current gradient coil type WB30SIdentical to the predicate devices, the proposed Ingenia Elition and MR 7700 MR Systems are intended to be marketed with the following pulse sequences and coils that are previously 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 (identical to the predicate devices)
Indications for Use:	There are no changes to the indications for use statement, provided below, of the proposed Ingenia Elition and MR 7700 MR Systems when compared to the primary predicate device MR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) and secondary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022):
Design Features/FundamentalScientificTechnology:	"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 structure ofthe head, body or extremities, in any orientation, representing the spatialdistribution of protons or other nuclei with spin.Image appearance is determined by many different physical properties ofthe tissue and the anatomy, the MR scan technique applied, andpresence of contrast agents.The use of contrast agents for diagnostic imaging applications should beperformed consistent with the approved labeling for the contrast agent.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 of physicalparameters, when interpreted by a trained physician, provide informationthat may assist diagnosis and therapy planning. The accuracy ofdetermined physical parameters depends on system and scanparameters and must be controlled and validated by the clinical user.In addition, the Philips MR systems provide imaging capabilities, such asMR fluoroscopy, to guide and evaluate interventional and minimallyinvasive procedures in the head, body and extremities. MR Interventionalprocedures, performed inside or adjacent to the Philips MR system, mustbe performed with MR Conditional or MR Safe instrumentation asselected and evaluated by the clinical user for use with the specific MRsystem configuration in the hospital. The appropriateness and use ofinformation from a Philips MR system for a specific interventionalprocedure and specific MR system configuration must be validated bythe clinical user".
	Same as the predicate devices, the proposed Ingenia Elition and MR7700 MR Systems are based on the principle that certain atomic nucleipresent in the human body will emit a weak relaxation signal whenplaced in a strong magnetic field and excited by a radio signal at theprecession frequency. The emitted relaxation signals are analyzed by thesystem and a computed image reconstruction is displayed on a videoscreen.The principal technological components (magnet, transmit body coil,gradient coil, gradient amplifier, RF amplifier and patient support) of theproposed Ingenia Elition and MR 7700 MR Systems are fundamentallythe same as those used in the legally marketed primary predicate deviceMR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) andsecondary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in a large, bold, sans-serif font. The word is in a bright blue color. The background is white, which makes the blue color stand out.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and appears to be a standard typeface.

	and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). The
	gradient coil has a minor modification which does not affect the
	technological characteristics of the gradient coil.
Summary ofNon-ClinicalPerformanceData:	No.	RecognitionNumber	StandardNumber andDate	Standard Name
	1	12-295	IEC60601-2-33Ed. 3.2:2010 +Amd 1:2013 +Amd 2:2015	Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
	2	19-4	ANSI / AAMIES60601-1:2005/(R)2012and A1:2012	Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2006, MOD).
	3	19-8	IEC60601-1-2Ed. 4.0:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances Requirements and tests
	4	5-89	IEC 60601-1-6Ed. 3.1:2010 +Amd 1:2013	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
	5	5-76	IEC 60601-1-8Ed. 2.1:2006 +Amd 1:2012(Ed.2.1)	Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
	6	5-125	ISO 14971 ThirdEdition 2019	Medical devices – Application of risk management to medical devices.
	7	5-114	IEC 62366-1 Ed.1.0:2015	Medical devices – Part 1: Application of usability engineering to medical devices
	8	13-79	IEC 62304 Ed.1.1:2015	Medical device software - Software life cycle processes.
Non-Clinical verification tests have been performed with regards to the requirement specifications and the risk management results.The verification test results demonstrate that the proposed Ingenia Elition and MR 7700 MR Systems meet the acceptance criteria and are adequate for the intended use.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.

	The validation testing performed with the primary and secondarypredicate devices remain valid for the changes introduced with theproposed device Ingenia Elition and MR 7700 MR Systems.
	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 Ingenia Elition and MR 7700 MR Systems aresubstantially equivalent to the legally marketed primary predicate deviceMR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) andsecondary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elitionand Ingenia Ambition MR Systems R11 (K213583, 04/15/2022), in termsof safety and effectiveness.
Summary ofClinical Data:	The proposed Ingenia Elition and MR 7700 MR Systems did notintroduce any modification to the indication for use or technologicalcharacteristics relative to the predicate devices that would require clinicaltesting.
SubstantialEquivalence:	The proposed Ingenia Elition and MR 7700 MR Systems and thelegally marketed primary predicate device MR 5300 and MR 7700 R11MR Systems (K223442, 12/23/2022) and secondary predicate deviceAchieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MRSystems R11 (K213583, 04/15/2022), have the same indications for usewith respect to the following:• Providing cross-sectional images based on the magnetic resonancephenomenon• Interpretation of the images is the responsibility of trained physicians• Images can be used for interventional and treatment planningpurposes
Conclusion:	The proposed Ingenia Elition and MR 7700 MR Systems aresubstantially equivalent to the legally marketed primary predicate deviceMR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) andsecondary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elitionand Ingenia Ambition MR Systems R11 (K213583, 04/15/2022), in termsof design features, fundamental scientific technology, indications for use,and safety and effectiveness.
	Additionally, substantial equivalence is demonstrated with non-clinicalperformance tests and compliance with the requirements specified in theinternational and FDA-recognized consensus standards and device-specific guidance.
	The results of these tests demonstrate that the proposed Ingenia Elitionand MR 7700 MR Systems meet the acceptance criteria and areadequate 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.