i Field 1.5T Superconducting Magnetic Resonance Imaging device, which is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MRI System produces transverse, sagittal, coronal, and oblique images that display the internal structure of the head, body, or extremities. The images produced by the MRI System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-latice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained-physician, these images provide information that can be useful in diagnosis determination.

Device Description

i Field 1.5T Superconducting Magnetic Resonance Imaging System utilizes a 1.5 Tesla superconducting magnet in an open gantry design. i Field 1.5T Superconducting Magnetic Resonance Imaging System has been designed to enhance clinical utility as compared to the i_Space 1.5T by taking advantage of the imaging properties of the 1.5T magnet.

AI/ML Overview

The provided document describes a 510(k) Summary for the i_Field 1.5T Superconducting Magnetic Resonance Imaging System, seeking substantial equivalence to a predicate device. This document is a regulatory submission to the FDA, not a clinical study report proving a device meets specific clinical performance acceptance criteria for an AI algorithm.

Therefore, many of the requested details regarding acceptance criteria for an AI device, sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a training set are not applicable to this document. This submission focuses on demonstrating the substantial equivalence of a new MR scanner to an existing one, primarily through technological comparison and adherence to performance and safety standards, rather than proving the performance of an AI-powered diagnostic algorithm.

However, I can extract information related to the device specifications and non-clinical testing that serve as "acceptance criteria" for an MR imaging system itself, and how the manufacturer proves the device meets these criteria.

Non-AI Device Acceptance Criteria and Performance (Based on provided 510(k) Summary)

The "acceptance criteria" for this MRI system are primarily defined by adherence to recognized national and international standards for medical electrical equipment and specific MRI performance parameters, and by demonstrating substantial equivalence to a predicate device. The performance data provided is largely in the form of conformance to these standards and similar technical specifications.

Here's an attempt to structure the available information relevant to "acceptance criteria" for the MRI system, understanding that it's for the hardware and basic imaging functions, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for an MRI system, the "acceptance criteria" are the established performance and safety specifications for such devices, often set by regulatory guidance and industry standards. The "reported device performance" is the manufacturer's claim of compliance and comparability to the predicate.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (Claimed)
Safety Parameters	Maximum Static Field	Conforms to FDA guidance
	Rate of Change of Magnetic Field	Conforms to FDA guidance
	RF Power Deposition	Conforms to FDA guidance
	Acoustic Noise Levels	Conforms to FDA guidance (NEMA MS 4-2010 for measurement)
Performance Levels	Specification Volume	Conforms to FDA guidance
	Signal to Noise (SNR)	Conforms to FDA guidance (NEMA MS 1-2008 (R2020), NEMA MS 6-2008 (R2020))
	Image Uniformity	Conforms to FDA guidance (NEMA MS 3-2008 (R2020), NEMA MS 6-2008 (R2020))
	Geometric Distortion	Conforms to FDA guidance (NEMA MS 2-2008 (R2020), NEMA MS 12-2016)
	Slice Profile, Thickness and Gap	Conforms to FDA guidance (NEMA MS 5-2018)
	High Contrast Spatial Resolution	Conforms to FDA guidance
General Safety & Performance Standards	Medical Electrical equipment (AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 60601-1-6)	Complies with listed standards
	Risk Management (ISO 14971)	Complies with standard
	Usability Engineering (IEC 62366-1)	Complies with standard
	Software Life Cycle Processes (IEC 62304)	Complies with standard
	MRI Equipment Image Quality (IEC 62464-1)	Complies with standard
	DICOM Compatibility (PS 3.1 - 3.20)	DICOM3.0 compatibility
	Biological Evaluation (ISO 10993-1)	Complies with standard
	RF Coil Heating (NEMA MS 14-2019)	Complies with standard
	Phased Array Coils (NEMA MS 9-2008 (R2020))	Complies with standard
Technological Characteristics	Magnet Type, Strength, Mass, Leakage flux	Same as predicate (Superconducting, 1.5T, 4.3ton, 2.5m x 4.0m)
	Gradient Max Strength & Slew Rate	Same as predicate (33mT/m, 128mT/m/ms)
	RF System Power Amplifier	Same as predicate (20kW)
	Imaging Methods (SE, FSE, IRPS, GEPS, EPI)	Same as predicate
	Scan Matrix, Slice Plane, FOV, File Format, Image Processing functions	Same as predicate
	Patient-accessible bore dimension	Better than predicate (710mm vs 600mm) – noted as improvement
	Slice thickness (typical, minimum)	Same as predicate (5mm +/- 1mm; 0.05mm(3D) min)

2. Sample size used for the test set and the data provenance

Not applicable / Not specified in this document for clinical performance. This document describes the non-clinical testing and technical specifications of an MRI scanner. The testing relies on phantom measurements and engineering verification against standards, not a clinical test set with patient data for an AI algorithm.
The "performance data provided" refers to engineering tests and measurements to confirm compliance with the listed standards (e.g., NEMA standards for SNR, uniformity, distortion), typically using phantoms rather than human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document does not describe a study involving expert readers establishing ground truth for a diagnostic AI algorithm. The "ground truth" for the device's technical performance is defined by the physical properties measured in phantoms and the specifications in the standards.

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

Not applicable. There is no clinical test set requiring adjudication in this 510(k) submission.

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. This document does not describe an AI device, nor an MRMC study comparing human reader performance with and without AI.

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

No. This is a submission for an MRI scanner, not a standalone AI algorithm.

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

For the technical performance of the MRI system, the "ground truth" is established by:
- Validated physical phantom measurements: For parameters like SNR, image uniformity, geometric distortion, slice thickness, etc., as specified by NEMA and IEC standards.
- Engineering specifications and design documents: For hardware characteristics (e.g., magnet strength, gradient slew rate, RF power).
- Compliance with recognized standards: The "truth" is whether the device meets the thresholds and methodologies defined in standards like IEC 60601 series, ISO 14971, NEMA MS series, etc.

8. The sample size for the training set

Not applicable. There is no AI training set described in this 510(k) submission for an MRI system.

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

Not applicable. As above, no AI training set is discussed.

In summary: The provided FDA 510(k) Summary is for an "i_Field 1.5T Superconducting Magnetic Resonance Imaging System," which is a medical imaging device (hardware and basic imaging software), not an AI algorithm. Therefore, the "acceptance criteria" and "proof" primarily revolve around demonstrating:

Compliance with safety and performance standards for MRI systems (e.g., IEC, NEMA).
Substantial equivalence in technological characteristics and intended use to a previously cleared predicate MRI device.
Non-clinical testing (e.g., phantom studies, engineering validations) to verify these characteristics and compliance.

The document explicitly states: "The minor differences in technological characteristics do not constitute any safety and effectiveness issue, as indicated in performance data provided." and "i Field 1.5T Superconducting Magnetic Resonance Imaging System will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to currently available system." This underscores that the "proof" is largely attestations of compliance supported by manufacturer's internal testing against these established benchmarks.

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). On the left is the Department of Health and Human Services logo. To the right of that 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.

July 1, 2022

MRI Division,Beijing Wandong Medical Technology Co.,Ltd. % Wang Huan MRI Division manager No.38, Chaoyang Road, Chaoyang District Beijing, Beijing 100024 CHINA

Re: K221025

Trade/Device Name: i Field 1.5T Superconducting Magnetic Resonance Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: March 15, 2022 Received: April 6, 2022

Dear Wang Huan:

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

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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 (OS) 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 mediation-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

Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy 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)

K221025

Device Name

i Field 1.5T Superconducting Magnetic Resonance Imaging System

Indications for Use (Describe)

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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K221025

510(K) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K221025

1 Submitter's information

1.1 Name: MRI Division, Beijing Wandong Medical Technology Co., Ltd.
1.2 Address: NO.38. Chaoyang Road, Chaoyang District, Beijing 100024, China
1.3 Telephone number: +86 10 65794660
1.4 Fax number: +86 10 65477303
1.5 Contact person: Mr. Wang Huan
1.6 Date of prepared:01/25/2022

2 Device's information

2.1 Classification name: Magnetic Resonance Diagnostic Device
2.2 Product code: LNH
2.3 Trade/Proprietary name: i_Field 1.5T Superconducting Magnetic Resonance Imaging System
2.4 Common Name: Superconducting Magnetic Resonance Imaging System
2.5 Regulation number:21 CFR 892.1000
2.6 Review panel: Radiology

3 Identification of Predicate Devices

3.1 510K Number: K192650
3.2 Manufacturer: Beijing Wandong Medical Technology Co., Ltd.
3.3 Trade Name: i_Space 1.5T Superconducting Magnetic Resonance Imaging System

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4 Indications for Use

i_Field 1.5T Superconducting Magnetic Resonance Imaging System is an imaging device, which is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MRI System produces transverse, sagittal, coronal, and oblique images that display the internal structure of the head, body, or extremities. The images produced by the MRI System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained-physician, these images provide information that can be useful in diagnosis determination.

5 Device Description

5.1 Function

i_Field 1.5T Superconducting Magnetic Resonance Imaging System utilizes a 1.5 Tesla superconducting magnet in an open gantry design. i Field 1.5T Superconducting Magnetic Resonance Imaging System has been designed to enhance clinical utility as compared to the i_Space 1.5T by taking advantage of the imaging properties of the 1.5T magnet.

5.2 Scientific Concepts

Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause s re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2.

A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial

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distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

5.3 Physical and performance characteristics

MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In MR imaging, difference in proton density, blood flow, and T1 and T2 relaxation times can all contribute to image contrast. By varying the pulse sequence characteristics, the resulting images can emphasize T1, T2, proton density, or the molecular diffusion of water or other proton containing molecules.

6 Technological Characteristics

The technological characteristics of this device are similar to the primary predicate device. The minor differences in technological characteristics do not constitute any safety and effectiveness issue, as indicated in performance data provided. The control and image processing hardware and the base elements of the system software are identical to the predicate device.

i_Field 1.5T Superconducting Magnetic Resonance Imaging System is of comparable type and substantially equivalent to i_Space 1.5T Superconducting Magnetic Resonance Imaging System (K192650) in that they are similar in technology and intended uses. Both of these systems are superconducting magnetic resonance imaging system, use gradient subsystem to provide controlled and uniform gradient magnet fields in the X, Y and Z directions, and use RF subsystem to complete the function of RF signal transmitting/receiving and processing. Image reconstruction is controlled by console that has an interactive user interface, and the system produces 2D and 3D image that can be filmed or electronically stored for future review. Both of these systems have the traditional MRI units.

The following are the safety parameter with action levels:

A Maximum Static Field
A Rated of Change of Magnetic Field
A RF Power Deposition
Acoustic Noise Levels A

and performance levels:

A Specification Volume
A Signal to Noise
Image Uniformity
A Geometric Distortion
A Slice Profile, Thickness and Gap
A High Contrast Spatial Resolution

specified by the FDA guidance document for MR Diagnostic Devices that will be

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evaluated. i Field 1.5T Superconducting Magnetic Resonance Imaging System will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to currently available system.

7 Non-clinical Testing

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards.

AAMI / ANSI ES60601-1:2005/(R)2012+A1:2012 Medical electrical equipment A - Part 1: General requirements for basic safety and essential performance
A IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1- 2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
A IEC 60601-2-33 Ed. 3.2 B:2015 Medical electrical equipment - Part 2- 33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic
ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment - Part 1- 6: General requirements for basic safety and essential performance - Collateral standard: Usability
A IEC 62366-1 Edition 1.1 2020-06 Medical devices - Application of usability engineering to medical devices
A IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
A IEC 62464-1:2018 Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set
ISO 10993-1 Fifth Edition 2018-08 Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process
A NEMA MS 1-2008 (R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
A NEMA MS 2-2008 (R2020) Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
A NEMA MS 3-2008 (R2020) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
A NEMA MS 4-2010 Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices

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NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic A Resonance Imaging
NEMA MS 6-2008 (R2020) Determination of Signal-to-Noise Ratio and Image A Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
A NEMA MS 9-2008 (R2020) Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
A NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special Applications
NEMA MS 14-2019 Standard for Characterization of Radiofrequency (RF) Coil A Heating in Magnetic Resonance Imaging Systems

8 Substantial Equivalence and Conclusion

ComparisonItem	Subject Device	Predicate DeviceK192650	Difference analysis
Product code	LNH	LNH	Same
RegulationNo.	21 CFR 892.1000	21 CFR 892.1000	Same
Class	II	II	Same
Indicationsfor use	i_Field 1.5TSuperconductingMagnetic ResonanceImaging System is animaging device, which isintended to provide thephysician withphysiological and clinicalinformation, obtainednon-invasively andwithout the use ofionizing radiation.	i_Field 1.5TSuperconductingMagnetic ResonanceImaging System is animaging device, which isintended to provide thephysician withphysiological and clinicalinformation, obtainednon-invasively andwithout the use ofionizing radiation.	Same
	The MRI Systemproduces transverse,sagittal, coronal, andoblique images thatdisplay the internalstructure of the head,body, or extremities.	The MRI Systemproduces transverse,sagittal, coronal, andoblique images thatdisplay the internalstructure of the head,body, or extremities.	Same
	The images produced bythe MRI System reflectthe spatial distributionof protons (hydrogennuclei) exhibitingmagnetic resonance.	The images produced bythe MRI System reflectthe spatial distribution ofprotons (hydrogennuclei) exhibitingmagnetic resonance.	Same
	The NMR propertiesthat determine theimage appearance areproton density,spin-lattice relaxationtime (T1), spin-spinrelaxation time (T2) andflow.	The NMR properties thatdetermine the imageappearance are protondensity, spin-latticerelaxation time (T1),spin-spin relaxation time(T2) and flow.	Same
	When interpreted by atrained-physician, theseimages provideinformation that can beuseful in diagnosisdetermination.	When interpreted by atrained-physician, theseimages provideinformation that can beuseful in diagnosisdetermination.	Same
Environmentof use	Hospital	Hospital	Same
Magnet
Type	Superconducting	Superconducting	Same
Strength	1.5 Tesla	1.5 Tesla	Same
Dimension(L×W×H)	1498mm×1880mm×2320mm	1596mm×2028mm×2386mm	Similar
Dimensionsof thepatient-accessible bore	710mm	600 mm	Better, enlargedaperture for greateropenness and patientspace
Field
Mass	4.3ton	4.3ton	Same
Leakageflux(0.5mT)	2.5m×4.0m (Radially ×Axially)	2.5m×4.0m (Radially ×Axially)	Same
Gradient
Maximummagneticstrength	33mT/m	33mT/m	Same
Maximumslew rate	128mT/m/ms	128T/m/s	Same
Cooling	Water	Water	Same
RF system
Poweramplifier	20kW	20kW	Same
Operator's Console
CPU	Intel ®core dure-core	Intel ®core dure-core	Same
Memory	4G	4G	Same
Hard disk	500G	500G	Same
Monitor	18′-21′TFT LCD	18′-21′TFT LCD	Same
Patient Table
Length	2600mm	2600mm	Same
Width	730mm	730mm	Same
Rang ofverticalmotion	Not less than 350mm	Not less than 350mm	Same


Horizontalstroke	Not less than 2000mm	Not less than 2000mm	Same
Imaging functions
Method	2D Fourier transform3D Fourier transform	2D Fourier transform3D Fourier transform	Same
Imagingcoverage	Whole body	Whole body	Same
Imagingmethods	Spin Echo (SE)Fast Spin EchoInversion Recovery PulseSequenceGradient Echo PulseEPI	Spin Echo (SE)Fast Spin EchoInversion Recovery PulseSequenceGradient Echo PulseEPI	Same





Scan matrix	64×64128×128256×256512×5121024×1024	64×64128×128256×256512×5121024×1024	Same
Slicethickness	a) Typical slicethickness is 5mm,the deviation isnot more than+1mm;	a) Typical slicethickness is 5mm,the deviation isnot more than +1mm;b) Minimum slice	Same




	b) Minimumthickness:(2D);0.05mm(3D)	slicethickness: 1mm (2D);1mm	0.05mm(3D)
Slice plane	Transverse planeSagittal planeCoronal planeOblique plane	Transverse planeSagittal planeCoronal planeOblique plane	Same
FOV	Minimum is 5mm×5mmand maximum is450mm×450mm.	Minimum is 5mm×5mmand maximum is450mm×450mm.	Same
File format	DICOM3.0compatibility	DICOM3.0compatibility	Same
Imageprocessing	ScanSystem icon fieldImage layoutDisplay and hiding outimagesShutterImage display modeSelected imagesImages synchronizationAdjust W/LZooming imagesMoving imagesMagnify imagesReset imagesRotation imagesROI statisticsMeasure distance andangelMeasure pointcomment textImage filterMIPMPRFilmMOVIE	ScanSystem icon fieldImage layoutDisplay and hiding outimagesShutterImage display modeSelected imagesImages synchronizationAdjust W/LZooming imagesMoving imagesMagnify imagesReset imagesRotation imagesROI statisticsMeasure distance andangelMeasure pointcomment textImage filterMIPMPRFilmMOVIE	Same

Comparison of Technological Characteristics with the Predicate Device:

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i_Field 1.5T Superconducting Magnetic Resonance Imaging System has the same intended use and similar technological characteristics than the predicate device system, i_Space 1.5T Superconducting Magnetic Resonance Imaging System, with respect to the

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magnetic resonance features and functionalities. The console, gradient, RF system, patient table, operator's console and imaging functions have the same major technological characteristics as the predicate device, which any minor differences in physical attributes do not constitute any safety and effectiveness issue, as indicated in performance data provided.

In summary, it is the opinion of Beijing Wandong Medical Technology Co., Ltd. that i_Field 1.5T Superconducting Magnetic Resonance Imaging System does not raise new questions of safety or effectiveness and is substantially equivalent to the listed predicate device, i_Space 1.5T Superconducting Magnetic Resonance Imaging System (K192650).

9 Conclusions

Based on the comparison and analysis above, the proposed device is as safe, as effective, and performs as well as the legally marketed 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.