i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
Device Facts
| Record ID | K221025 |
|---|---|
| Device Name | i_ Field 1.5T Superconducting Magnetic Resonance Imaging System |
| Applicant | Mri Division,Beijing Wandong Medical Technology Co., Ltd. |
| Product Code | LNH · Radiology |
| Decision Date | Jul 1, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
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.
Device Story
The i_Field 1.5T is a superconducting MRI system using a 1.5T magnet in an open gantry design. It detects RF emissions (echoes) from hydrogen nuclei in a static magnetic field, spatially encoded via magnetic field gradients (X, Y, Z). The system transforms these signals into 2D/3D anatomical images using Fourier transform-based reconstruction. Operated by clinicians in hospital settings, the device provides images for diagnostic interpretation. It supports various pulse sequences (SE, Fast SE, Inversion Recovery, Gradient Echo, EPI). The system includes an operator console for image processing, measurement, and display. Benefits include high-quality anatomical imaging without ionizing radiation. The device is intended for whole-body imaging to assist physicians in diagnosis.
Clinical Evidence
Bench testing only. Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, and NEMA MS series standards (SNR, geometric distortion, uniformity, slice thickness, acoustic noise, RF coil heating) confirms safety and performance equivalence to the predicate.
Technological Characteristics
1.5T superconducting magnet; open gantry (710mm bore); water cooling; 20kW RF power amplifier. Imaging: 2D/3D Fourier transform; SE, Fast SE, Inversion Recovery, Gradient Echo, EPI sequences. Connectivity: DICOM 3.0. Software: IEC 62304 compliant. Standards: NEMA MS 1-14, IEC 60601-2-33, ISO 10993-1.
Indications for Use
Indicated for use as a non-invasive diagnostic imaging device to produce transverse, sagittal, coronal, and oblique images of the head, body, or extremities in patients, providing physiological and clinical information based on proton density, T1, T2, and flow properties.
Regulatory Classification
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).
Special Controls
*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.
Predicate Devices
- i_Space 1.5T Superconducting Magnetic Resonance Imaging System (K192650)
Submission Summary (Full Text)
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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)
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.
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
| Comparison<br>Item | Subject Device | Predicate Device<br>K192650 | Difference analysis |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Product code | LNH | LNH | Same |
| Regulation<br>No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| Indications<br>for use | i_Field 1.5T<br>Superconducting<br>Magnetic Resonance<br>Imaging System is an<br>imaging device, which is<br>intended to provide the<br>physician with<br>physiological and clinical<br>information, obtained<br>non-invasively and<br>without the use of<br>ionizing radiation. | i_Field 1.5T<br>Superconducting<br>Magnetic Resonance<br>Imaging System is an<br>imaging device, which is<br>intended to provide the<br>physician with<br>physiological and clinical<br>information, obtained<br>non-invasively and<br>without the use of<br>ionizing radiation. | Same |
| | The MRI System<br>produces transverse,<br>sagittal, coronal, and<br>oblique images that<br>display the internal<br>structure of the head,<br>body, or extremities. | The MRI System<br>produces transverse,<br>sagittal, coronal, and<br>oblique images that<br>display the internal<br>structure of the head,<br>body, or extremities. | Same |
| | The images produced by<br>the MRI System reflect<br>the spatial distribution<br>of protons (hydrogen<br>nuclei) exhibiting<br>magnetic resonance. | The images produced by<br>the MRI System reflect<br>the spatial distribution of<br>protons (hydrogen<br>nuclei) exhibiting<br>magnetic resonance. | Same |
| | The NMR properties<br>that determine the<br>image appearance are<br>proton density,<br>spin-lattice relaxation<br>time (T1), spin-spin<br>relaxation time (T2) and<br>flow. | The NMR properties that<br>determine the image<br>appearance are proton<br>density, spin-lattice<br>relaxation time (T1),<br>spin-spin relaxation time<br>(T2) and flow. | Same |
| | When interpreted by a<br>trained-physician, these<br>images provide<br>information that can be<br>useful in diagnosis<br>determination. | When interpreted by a<br>trained-physician, these<br>images provide<br>information that can be<br>useful in diagnosis<br>determination. | Same |
| Environment<br>of use | Hospital | Hospital | Same |
| Magnet | | | |
| Type | Superconducting | Superconducting | Same |
| Strength | 1.5 Tesla | 1.5 Tesla | Same |
| Dimension(L×<br>W×H) | 1498mm×1880mm×232<br>0mm | 1596mm×2028mm×238<br>6mm | Similar |
| Dimensions<br>of the<br>patient-acces<br>sible bore | 710mm | 600 mm | Better, enlarged<br>aperture for greater<br>openness and patient<br>space |
| Field | | | |
| Mass | 4.3ton | 4.3ton | Same |
| Leakage<br>flux(0.5mT) | 2.5m×4.0m (Radially ×<br>Axially) | 2.5m×4.0m (Radially ×<br>Axially) | Same |
| Gradient | | | |
| Maximum<br>magnetic<br>strength | 33mT/m | 33mT/m | Same |
| Maximum<br>slew rate | 128mT/m/ms | 128T/m/s | Same |
| Cooling | Water | Water | Same |
| RF system | | | |
| Power<br>amplifier | 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 of<br>vertical<br>motion | Not less than 350mm | Not less than 350mm | Same |
| | | | |
| | | | |
| Horizontal<br>stroke | Not less than 2000mm | Not less than 2000mm | Same |
| Imaging functions | | | |
| Method | 2D Fourier transform<br>3D Fourier transform | 2D Fourier transform<br>3D Fourier transform | Same |
| Imaging<br>coverage | Whole body | Whole body | Same |
| Imaging<br>methods | Spin Echo (SE)<br>Fast Spin Echo<br>Inversion Recovery Pulse<br>Sequence<br>Gradient Echo Pulse<br>EPI | Spin Echo (SE)<br>Fast Spin Echo<br>Inversion Recovery Pulse<br>Sequence<br>Gradient Echo Pulse<br>EPI | Same |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| Scan matrix | 64×64<br>128×128<br>256×256<br>512×512<br>1024×1024 | 64×64<br>128×128<br>256×256<br>512×512<br>1024×1024 | Same |
| Slice<br>thickness | a) Typical slice<br>thickness is 5mm,<br>the deviation is<br>not more than<br>+1mm; | a) Typical slice<br>thickness is 5mm,<br>the deviation is<br>not more than +1mm;<br>b) Minimum slice | Same |
| | | | |
| | | | |
| | | | |
| | | | |
| | b) Minimum<br>thickness:<br>(2D);<br>0.05mm(3D) | slice<br>thickness: 1mm (2D);<br>1mm | 0.05mm(3D) |
| Slice plane | Transverse plane<br>Sagittal plane<br>Coronal plane<br>Oblique plane | Transverse plane<br>Sagittal plane<br>Coronal plane<br>Oblique plane | Same |
| FOV | Minimum is 5mm×5mm<br>and maximum is<br>450mm×450mm. | Minimum is 5mm×5mm<br>and maximum is<br>450mm×450mm. | Same |
| File format | DICOM3.0compatibility | DICOM3.0compatibility | Same |
| Image<br>processing | Scan<br>System icon field<br>Image layout<br>Display and hiding out<br>images<br>Shutter<br>Image display mode<br>Selected images<br>Images synchronization<br>Adjust W/L<br>Zooming images<br>Moving images<br>Magnify images<br>Reset images<br>Rotation images<br>ROI statistics<br>Measure distance and<br>angel<br>Measure point<br>comment text<br>Image filter<br>MIP<br>MPR<br>Film<br>MOVIE | Scan<br>System icon field<br>Image layout<br>Display and hiding out<br>images<br>Shutter<br>Image display mode<br>Selected images<br>Images synchronization<br>Adjust W/L<br>Zooming images<br>Moving images<br>Magnify images<br>Reset images<br>Rotation images<br>ROI statistics<br>Measure distance and<br>angel<br>Measure point<br>comment text<br>Image filter<br>MIP<br>MPR<br>Film<br>MOVIE | 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.
