(493 days)
i Space 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-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.
i Space 1.5T Superconducting Magnetic Resonance Imaging System utilizes a 1.5 Tesla superconducting magnet in an open gantry design. i Space 1.5T Superconducting Magnetic Resonance Imaging System has been designed to enhance clinical utility as compared to the HHF1 by taking advantage of the imaging properties of the 1.5T magnet.
The provided text describes the 510(k) summary for the i Space 1.5T Superconducting Magnetic Resonance Imaging System, establishing substantial equivalence to a predicate device (HHF1 Magnetic Resonance Imaging System, K052172).
However, the document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or details of a study that directly proves the device meets specific performance acceptance criteria for image quality or diagnostic accuracy in the way described by the prompt's request (e.g., in terms of clinical sensitivity, specificity, accuracy, or reader performance).
Instead, the submission focuses on demonstrating substantial equivalence by comparing technological characteristics and adherence to recognized standards. The "study" mentioned refers to non-clinical tests verifying design specifications and compliance with safety and performance standards.
Therefore, I cannot fulfill all parts of your request with the provided information. I will extract the relevant information that is present and indicate where information is missing.
Description of Acceptance Criteria and Proving Study for i Space 1.5T Superconducting Magnetic Resonance Imaging System
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the i Space 1.5T Superconducting Magnetic Resonance Imaging System to a predicate device rather than providing a detailed clinical study with diagnostic performance acceptance criteria. The "study" referenced in the document is a series of non-clinical tests to verify compliance with design specifications and recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "safety parameters with action levels" and "performance levels" that will be evaluated according to FDA guidance and NEMA/IEC standards. However, actual numerical acceptance criteria (e.g., specific SNR thresholds, uniformity percentages) are not explicitly stated in the provided text, nor are specific numerical results of the device's performance against such criteria. The document only confirms that "Non clinical tests were conducted to verify that the proposed device met all design specifications" and "The test results demonstrated that the proposed device complies with the following standards."
| Aspect | Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance (Implied as compliant with standards) |
|---|---|---|
| Maximum Static Field | Conforms to FDA guidance | Tested and found compliant with relevant standards. |
| Rate of Change of Magnetic Field | Conforms to FDA guidance | Tested and found compliant with relevant standards. |
| RF Power Deposition | Conforms to FDA guidance | Tested and found compliant with relevant standards. |
| Acoustic Noise Levels | Conforms to FDA guidance and NEMA MS 4-2010 | Tested and found compliant with relevant standards. |
| Specification Volume | Conforms to FDA guidance | Tested and found compliant with relevant standards. |
| Signal to Noise | Conforms to FDA guidance and NEMA MS 1-2008 (R2014) | Tested and found compliant with relevant standards. |
| Image Uniformity | Conforms to FDA guidance and NEMA MS 3-2008 (R2014) | Tested and found compliant with relevant standards. |
| Geometric Distortion | Conforms to FDA guidance and NEMA MS 2-2008 (R2014), NEMA MS 12-2016 | Tested and found compliant with relevant standards. |
| Slice Profile, Thickness, and Gap | Conforms to FDA guidance and NEMA MS 5-2018 | Tested and found compliant with relevant standards. |
| High Contrast Spatial Resolution | Conforms to FDA guidance | Tested and found compliant with relevant standards. |
2. Sample size used for the test set and the data provenance
The document refers to "non-clinical tests" and "test results" but does not specify a "test set" in terms of patient data, nor does it provide information on sample size, country of origin of data, or whether it was retrospective or prospective. The testing described is intrinsic device performance testing against engineering specifications and standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The non-clinical tests described would typically involve engineering measurements and phantom studies rather than expert-established ground truth from clinical cases.
4. Adjudication method for the test set
This information is not provided, as the nature of the test set is non-clinical device performance measurements.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not described or referenced in the provided text. The device is an MRI system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not described or referenced. The device is a whole MRI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be established physical or engineering properties and reference standards (e.g., phantom measurements, calibrated equipment). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests.
8. The sample size for the training set
This information is not applicable and not provided. The submission describes an MRI hardware system, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
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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, there 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.
MRI Division, Beijing Wandong Medical Technology Co., Ltd. January 29, 2021 % Zhou Lu Quality Engineer No.7 Sanjianfang Nanli, Chaoyang District Beijing, Beijing 100024 CHINA
Re: K192650
Trade/Device Name: i Space 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: December 17, 2020 Received: December 22, 2020
Dear Zhou Lu:
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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K192650/S001
Device Name
i Space 1.5T Superconducting Magnetic Resonance Imaging System
Indications for Use (Describe)
i Space 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-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.
| 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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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: K192650
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: 01/09/2021
2 Device's information
- 2.1 Classification name: Magnetic Resonance Diagnostic Device
- 2.2 Product code: LNH
- 2.3 Trade/Proprietary name: i Space 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: K052172
- 3.2 Manufacturer: Hitachi Medical Systems America, Inc.
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3.3 Trade Name: HHF1 Magnetic Resonance Imaging System
4 Indications for Use
i Space 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 Space 1.5T Superconducting Magnetic Resonance Imaging System utilizes a 1.5 Tesla superconducting magnet in an open gantry design. i Space 1.5T Superconducting Magnetic Resonance Imaging System has been designed to enhance clinical utility as compared to the HHF1 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
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changing the direction and strength of these gradients. Images depicting the spatial 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 Space 1.5T Superconducting Magnetic Resonance Imaging System is of comparable type and substantially equivalent to HHF1 Magnetic Resonance Imaging System (K052172) 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 Space 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 Second Edition 2007-03-01 Medical devices - Application of risk management to medical devices
-
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1- 6: General requirements for basic safety and essential performance - Collateral standard: Usability
- A IEC 62366-1 Edition 1.0 2015-02 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 03/16/2012 Radiology
- ISO 10993-1 Fifth Edition 2018-08 Biological Evaluation of Medical Devices > Part 1: Evaluation and Testing Within a Risk Management Process
- NEMA MS 1-2008 (R2014) Determination of Signal-to-Noise Ratio (SNR) in A Diagnostic Magnetic Resonance Images
- A NEMA MS 2-2008 (R2014) Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- A NEMA MS 3-2008 (R2014) 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 Resonance Imaging
- A NEMA MS 6-2008 (R2014) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- A NEMA MS 9-2008 (R2014) Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- A NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special Applications
- A NEMA MS 14-2019 Standard for Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
8 Substantial Equivalence and Conclusion
| ComparisonItem | Subject Device | Predicate Device | Difference analysis |
|---|---|---|---|
| Product code | LNH | LNHK052172 | Same |
| RegulationNo. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| Indicationsfor use | i_Space 1.5TSuperconductingMagnetic ResonanceImaging System is animaging device, whichis intended to providethe physician withphysiological andclinical information,obtainednon-invasively andwithout the use ofionizing radiation. | The HHFI MR systemis an imaging device,and is intended toprovide the physicianwith physiological andclinical information,obtained non-invasivelyand without the use ofionizing radiation. | Same |
| The MRI System | The MR system | Similar, this is because | |
| produces transverse,sagittal, coronal, andoblique images thatdisplay the internalstructure of the head,body, or extremities. | produces transverse,sagittal, coronal,oblique, and curvedcrosssectional imagesthat display the internalstructure of the head,body, or extremities. | transverse,sagittal, coronal, and obliqueimages can satisfy thei_Space 1.5T imageprocessing function, and issubstantially equivalent(SE) to the predicatedevice. | |
| The images producedby the MRI System | The images producedby the MR system | Same | |
| reflect the spatialdistribution ofprotons (hydrogennuclei) exhibitingmagnetic resonance. | reflect the spatialdistribution of protons(hydrogen nuclei)exhibiting magneticresonance. | ||
| The NMR propertiesthat determine theimage appearance areproton density,spin-lattice relaxationtime (T1), spin-spinrelaxation time (T2)and flow. | The NMR propertiesthat determine theimage appearance areproton density,spin-lattice relaxationtime (T1), spin-spinrelaxation time (T2),and flow. | Same | |
| When interpreted bya trained-physician,these images provideinformation that canbe useful 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) | 1596mm×2028mm×238 6mm | 1600mm×2100mm×220 0mm | Similar |
| Dimensionsof thepatient acces | 600 mm | 610 mm | Similar |
| sible borespace | |||
| Mass | 4.3ton | 5150kg | Similar |
| Leakage flux(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 | 150T/m/s | Relatively small, butcompletely satisfied withthe scanning sequence |
| Cooling | Water | Water | Same |
| RF system | |||
| Poweramplifier | 20kW | Output 20kW | Same |
| Operator's Console | |||
| CPU | Intel ®core dure-core | Dual core 2.13GHz | Computer performanceimprovement |
| Memory | 4G | 3GB | Computer performanceimprovement |
| Hard disk | 500G | Storage capacity 250GB Maximum400,000 images | Computer performanceimprovement |
| Monitor | 18'-21'TFT LCD | 24 inch LCD colordisplay | Similar |
| Patient Table | |||
| Length | 2600mm | 2350mm | Similar |
| Width | 730mm | 700 mm (table width:506mm) | Similar |
| Rang ofverticalmotion | Not less than 350mm | 495mm-852mm | It can satisfy the clinicaluse demand. |
| Horizontalstroke | Not less than2000mm | 2800mm | It can satisfy the clinicaluse demand. |
| 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 RecoveryPulse SequenceGradient Echo PulseEPI | Spin echoFast spin echoInversion recoveryimageGradient echo imageEPI imageFast inversionrecovery imageMR Angiographyimage | Similar, but differentstatements. |
| Scan matrix | 64×64128×128256×256512×5121024×1024 | (64-1024)×(64-1024)Increment by 4 | Same |
| Slicethickness | a) Typical slicethickness is 5mm,the deviation isnot more than+1mm;b) Minimum slicethickness:1mm (2D);0.05mm(3D) | 0.5-100mm(2D)0.05-10.0mm (3D) | Similar |
| Slice plane | Transverse planeSagittal planeCoronal planeOblique plane | Axial plane (Axial)Sagittal plane(Sagittal)Coronal plane(Coronal)Arbitrary obliqueplane (Single/Doubleoblique)Arbitrary intervalmulti- sliceArbitrary planemulti-slice | Similar, but differentstatements. |
| FOV | Minimum is5mm×5mm andmaximum is450mm×450mm. | 5-500mm | Similar |
| File format | DICOM 3.0 | DICOM 3.0 | Same |
| compatibility | compatibility | ||
| Imageprocessing | ScanSystem icon fieldImage layoutDisplay and hiding out imagesShutterImage display modeSelected imagesImages synchronizationAdjust W/LZooming imagesMoving imagesMagnify imagesReset imagesRotation imagesROI statisticsMeasure distance and angelMeasure pointcomment textImage filterMIPMPRFilmMOVIE | Protocol/TaskSystem toolsLayout toolUniversal toolsOverlay toolsMode selectionScroll toolsWW/ WL toolsMagnification/Shift toolsRotation/Reverse toolsROI toolsStatistical toolsMeasurement toolsComment toolsFilterMIPMPRFilmingCine tools | Similar, but different statements. |
Comparison of Technological Characteristics with the Predicate Device
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i Space 1.5T Superconducting Magnetic Resonance Imaging System has the same intended use and similar technological characteristics than the predicate device system, HHF1 Magnetic Resonance Imaging System, with respect to the magnetic resonance features and functionalities. The magnet, gradient, 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 Space 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, HHF1 Magnetic Resonance Imaging System (K052172).
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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.
§ 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.