(208 days)
NEONA 1.5T MRI system is indicated for use as a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
The NEONA 1.5T MRI System is a 1.5T superconducting magnet MRI system which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, Client PC, and Imaging Cabinet. The system software, Prodiva, a Windows-based software, is an interactive program with user friendly interface. The device is conformed to IEC and DICOM standards.
The sponsor, Time Medical Limited, has demonstrated the substantial equivalence of their NEONA 1.5T MRI System to a legally marketed predicate device (EMMA 1.5T MRI System, K183621) through non-clinical performance data and clinical images.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in a quantified manner for comparison. Instead, it focuses on demonstrating that the NEONA 1.5T MRI System performs as well as the predicate device and complies with recognized standards, indicating that meeting these standards and achieving comparable image quality to the predicate serves as the de facto acceptance.
The "Performance Data" section in the comparative table (page 9) implicitly suggests the acceptance criteria are compliance with:
- NEMA MS standards
- IEC standards: IEC 60601-1, IEC60601-1-2, IEC60601-2-33
The reported device performance is demonstrated by the non-clinical testing results and the sample clinical images.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with AAMI / ANSI ES60601-1 | Complied |
| Compliance with IEC 60601-1-2 | Complied |
| Compliance with IEC 60601-2-33 | Complied |
| Compliance with NEMA MS-1 (SNR) | Complied (performance testing results demonstrate safety and performance as expected) |
| Compliance with NEMA MS-2 (Geometric Distortion) | Complied |
| Compliance with NEMA MS-3 (Image Uniformity) | Complied |
| Compliance with NEMA MS-4 (Acoustic Noise) | Complied |
| Compliance with NEMA MS-5 (Slice Thickness) | Complied |
| Compliance with NEMA MS-6 (SNR and Uniformity for Single Coils) | Complied |
| Compliance with NEMA MS-8 (SAR) | Complied |
| Compliance with NEMA MS-9 (Phased Array Coils) | Complied |
| Compliance with NEMA MS-14 (RF Coil Heating) | Complied |
| Compliance with ISO 10993-1 (Biological Evaluation) | Complied |
| Compliance with ISO 10993-5 (Cytotoxicity) | Complied |
| Compliance with ISO 10993-10 (Irritation/Sensitization) | Complied |
| Capability in generating images for diagnostic purposes | Verified (Sample clinical images provided) |
| Substantial equivalence in clinical images to predicate device | Demonstrated (Sample clinical image sets from filing device and predicate device on same pulse sequences provided to justify substantial equivalence in medical diagnosis results) |
2. Sample size used for the test set and the data provenance
The document states: "Sample clinical images are provided to verify the claim of filing device's capability in generating images for diagnostic purposes." and "Sample clinical image sets from filing device and predicate device on same pulse sequences are provided to demonstrate the substantial equivalence of filing device to legally marketed predicate device."
- Sample Size: The exact number of clinical images or cases used in the test set is not specified in the provided document. It refers to "sample clinical images" and "sample clinical image sets."
- Data Provenance: The document does not specify the country of origin of the data nor whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that images are "interpreted by trained physician" to "assist medical diagnosis." However, it does not specify how many experts were involved in evaluating the sample clinical images for the substantial equivalence demonstration, nor does it detail their qualifications (e.g., years of experience, specific certifications).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for establishing ground truth or evaluating the clinical image sets. The phrasing "interpreted by trained physician" suggests individual interpretation but doesn't detail a consensus process.
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, an MRMC comparative effectiveness study was not done.
- The device in question, NEONA 1.5T MRI System, is a Magnetic Resonance Diagnostic Device (MRDD), which is the hardware system that produces images. It is not an AI-powered diagnostic software designed to assist human readers. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable to this submission. The comparison is between the performance of the new MRI system and a predicate MRI system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The NEONA 1.5T MRI System is an imaging device, not an algorithm, and its output (images) is explicitly intended to be "interpreted by trained physician." Therefore, a standalone algorithm-only performance assessment is not relevant in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the evaluation of the clinical images, the implicit ground truth appears to be the diagnostic information derived from the images when interpreted by trained physicians. The comparison of images from the filing device and the predicate device on the same pulse sequences suggests a direct visual and interpretive comparison, implying that the diagnostic conclusions reached from both sets of images should be comparable. However, no specific method like "pathology" or "outcomes data" is mentioned to serve as an independent, definitive ground truth reference beyond physician interpretation of the images themselves.
8. The sample size for the training set
This information is not applicable to the submission for the NEONA 1.5T MRI System. This device is a hardware MRI system, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would relate to its manufacturing, calibration, and quality control processes to ensure image quality, not to a dataset for an AI model.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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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 & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 21, 2023
Time Medical Limited % Nick Tse VP, Regulatory and Quality Systems Flat/Rm 301, 3/F 20E, 20 Science Park East Avenue Hong Kong Science Park Shatin, Hong Kong, HKSAR CHINA
Re: K222259
Trade/Device Name: NEONA 1.5T MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: January 12, 2023 Received: January 20, 2023
Dear Nick Tse:
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
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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,
FDA
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
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Indications for Use
510(k) Number (if known) K22259
Device Name NEONA 1.5T MRI System
Indications for Use (Describe)
NEONA 1.5T MRI system is indicated for use as a magnetic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal struction of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
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 OF SAFETY AND EFFECTIVENESS
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date of Submission: | |
|---|---|
| Sponsor: | Time Medical LimitedUnit 301, 20E, Science Park East Ave, Hong Kong Science Park,Shatin, New Territories, Hong Kong, ChinaContact Person: Nick Tse – VP, Regulatory and Quality SystemTelephone number: +852 21561711 (ext. 119) Fax.: +852 2156 0908 |
| Correspondent: | Time Medical LimitedUnit 301, 20E, Science Park East Ave, Hong Kong Science Park,Shatin, New Territories, Hong Kong, ChinaContact Person: Nick Tse – VP, Regulatory and Quality SystemTelephone number: +852 21561711 (ext. 119) Fax.: +852 2156 0908 |
| Filing Device: | NEONA 1.5T MRI System |
| Classification Name: | System. Nuclear Magnetic Resonance Imaging |
| Regulatory Description: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Class | Class II / LNH / 21 CFR 892. 1000 |
| Intended Use: | NEONA 1.5T MRI system is indicated for use as a magnetic resonancediagnostic device (MRDD) which produces transverse, sagittal, coronaland oblique cross-sectional images, and those display the internalstructure and/or function of the head, body, or extremities. Depending onthe region of interest, contrast agents may be used. These images wheninterpreted by trained physician yield information that may assist medicaldiagnosis. |
| Device Description: | The NEONA 1.5T MRI System is a 1.5T superconducting magnet MRIsystem which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or functionof the head, body, or extremities. It is composed of Magnet, MagnetEnclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil,Client PC, and Imaging Cabinet. The system software, Prodiva, aWindows-based software, is an interactive program with user friendlyinterface. The device is conformed to IEC and DICOM standards. |
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| General Comparison to Predicate Device: | |||
|---|---|---|---|
| -- | -- | ----------------------------------------- | -- |
| Comparison Element | Filing Device: | Predicate Device: |
|---|---|---|
| 510(k) Number | N.A. | K183621 |
| Model | 15000-02 | 15000-01 |
| Device Name | NEONA 1.5T MRI System | EMMA 1.5T MRI System |
| Applicant | Time Medical Limited | Time Medical Limited |
| Classification Name | System, Nuclear MagneticResonance Imaging | System, Nuclear MagneticResonance Imaging |
| Product Code | LNH | LNH |
| Regulation Number | 21 CFR 892.1000 | |
| Panel | Radiology | |
| Class | Class II | |
| Indications for Use | NEONA 1.5T MRI system isindicated for use as a magneticresonance diagnostic device(MRDD) which producestransverse, sagittal, coronal andoblique cross-sectional images, andthose display the internal structureand/or function of the head, body,or extremities. Depending on theregion of interest, contrast agentsmay be used. These images wheninterpreted by trained physicianyield information that may assistmedical diagnosis. | The EMMA 1.5T MRI System isindicated for use as a magneticresonance diagnostic device(MRDD) which producestransverse, sagittal, coronal andoblique cross-sectional images, andthose display the internal structureand/or function of the head, body,or extremities. Depending on theregion of interest, contrast agentsmay be used. These images wheninterpreted by trained physicianyield information that may assistmedical diagnosis. |
| The filing device has the same US FDA classification information including classification name,product code, regulation number, panel, and class with the predicate device. |
The filing device has the same major indications for use as the predicate device: the device produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be administrated according to physician's instructions. These images when interpreted by trained physician yield information that may assist medical diagnosis.
The minor differences in indications for use do not constitute any safety and effectiveness issue, as indicated in the performance data provided.
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| TechnologicalCharacteristics | NEONA 1.5T MRI system is based on the principle that certain atomic nuclei present in the human body, when placed in a strong magnetic field and excited by a radio frequency signal at the precession frequency, will emit a relaxation signal. The emitted relaxation signals are acquired by signal receiving coils and are analyzed by the system. Human- interpretable images are reconstructed by and stored in the computer and displayed on the screen. |
|---|---|
| The principal components of NEONA 1.5T MRI system includes Superconducting magnet with corresponding cooling devices Gradient system RF transmission and receive system Cooling system for different components of the system Patient table and support components Spectrometer Server/Client PC and application software | |
| The superconducting magnet is made of coils of superconducting wires and is cooled to and maintained at low temperature. When energized, current flows continuously inside the superconducting wires as a closed loop; thus producing a constant magnetic field. This has the same major technological characteristics as the predicate device. | |
| The gradient system consists of a gradient coil and the gradient amplifier. The gradient coil produces varying linear gradient fields in the three orthogonal spatial axes with currents given by the gradient amplifier. The gradient coil can also produce various non-linear gradients fields to improve the homogeneity of the main magnetic field. This has the same major technological characteristics as the predicate device. | |
| The RF transmission and receive system consists of the RF amplifier, the RF transmission coil and various RF receiver coils for receiving the relaxation signals emitted from the subject after RF transmission. They are coils made of copper wires tuned to transmit and receive around the designed frequency corresponding to the magnetic field strength. This has the same major technological characteristics as the predicate device. | |
| The cooling system maintains suitable operating temperatures for amplifiers and other system devices. This has the same major technological characteristics as the predicate device. | |
| The patient table and support components provide a comfortable platform for the patient and allows the operator to easily position the patient to the location for imaging. This has the same major technological characteristics as the predicate device. | |
| The spectrometer controls the execution of the pulse sequence for RF transmit and receive and gradient output. This has the same major technological characteristics as the predicate device. | |
| The server/client PC and the application software provides the operator a platform to configure scans and manage scanned data. Raw data received from the spectrometer is also reconstructed here. This has the | |
| same major technological characteristics as the predicate device. | |
| Therefore, the same scientific technology theory is applied to both theNEONA 1.5T MRI system and predicate device. | |
| Any minor differences in physical attributes do not constitute any safetyand effectiveness issue, as indicated in performance data provided. |
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| The filing device is claimed to comply with the following cited FDA recognized standards: | |
|---|---|
| AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010(R)2012(Cons.Text) [Incl.AMD2:2021] - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance [Including Amendment 2 (2021)] IEC 60601-1-2:2020 Edition 4.1 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests [Including Amendment 1 (2021)] IEC 60601-2-33:2015 - Medical Electrical Equipment - Part 2-33: Particular Requirements for The Basic Safety and Essential Performance of Magnetic Resonance Equipment for Medical Diagnostic NEMA MS-1-2008 (R2020) - Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images NEMA MS 2-2008 (R2020) - Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images NEMA MS 3-2008 (R2020) - Determination of Image Uniformity in Diagnostic Magnetic Resonance Images NEMA MS 4-2010 - Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices NEMA MS 5-2018 - Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging NEMA MS 6-2008 (R2014) - Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging NEMA MS 8-2016 - Characterization of The Specific Absorption Rate For Magnetic Resonance Imaging Systems NEMA MS 9-2008 (R2020) - Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images NEMA MS 14-2019 - Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Edition 3 - Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ISO 10993-10:2010 Edition 3 - Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, dated November 18, 2016 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005 Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway, dated December 11, 2020 | |
| Non-Clinical Testing Summary: | The performance testing results demonstrate the safety and performance as expected. Therefore, the filing device is substantially equivalent to the legally marketed predicate device. |
| Clinical Testing Summary: | Sample clinical images are provided to verify the claim of filing device's capability in generating images for diagnostic purposes. Sample clinical image sets from filing device and predicate device on same pulse sequences are provided to demonstrate the substantial equivalence of filing device to legally marketed predicate device |
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| Conclusions Drawnfrom Non-ClinicalInformation andClinical Images: | The non-clinical information (safety and performance tests), combinedwith clinical images (both from filing device and predicate device),demonstrate that the filing device is as safe, as effective, and performs aswell as the predicate device. |
|---|---|
| SE Conclusion: | The filing device has the same intended use as the predicate device. Theminor differences in indication for use do not constitute any safety andeffectiveness issue, as indicated in performance data provided.The filing device utilizes same technologies as predicate device, andgives consistent results (images) in medical diagnosis. Any minordifferences in physical attributes do not constitute any safety andeffectiveness issue, as indicated in performance data (non-clinical/clinical) provided.Therefore the filing device is demonstrated, for being substantiallyequivalent to the legally marketed predicate device. |
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ADDITIONAL INFORMATION
| General | Filing Device | Predicate Device |
|---|---|---|
| Design | Cylindrical | Cylindrical |
| Materials | FRP, ABS | |
| Power Source | Isolated power supply | |
| Performance Data | Comply with:- NEMA MS standardsIEC standards: IEC 60601-1,IEC60601-1-2,IEC60601-2-33 | |
| Magnet | Filing Device | Predicate Device |
| Type | Superconducting | |
| Field Strength | 1.5T | |
| Weight | 2,987 kg | 3,200 kg |
| Overall Dimensions | 1378 x 1736 x 2148 mm(L x W x H) | 1497 x 1880 x 2421 mm(L x W x H) |
| Cryogen Type | Liquid helium free magnet bore,with 4K cryo-compressor | Liquid Helium |
| Spatial Homogeneity | 3.04 ppm (rms) at 40cm DSV | 1.45 ppm at 40 cm DSV |
| Fringe Field | 5 gauss line < 3m radial x 4maxial | 5 gauss line < 2.5m radial x 4maxial |
| Magnet Room Lighting | For sufficient and even lighting, 16overhead lamps (100 lumen each)recommended | For sufficient and even lighting, 16overhead lamps (100 lumen each)recommended |
| Room Ventilation | HVAC is installed for ventilation. | |
| Gradient System | Filing Device | Predicate Device |
| Amplitude | 52.0mT/m | 43.6 mT/m |
| Rise time | 366μs | 0.17 ms |
| Slew rate | 142T/m/s | 257 T/m/s |
| Patient Table | Filing Device | Predicate Device |
| Dimensions (L x W x H) | 88.6 x 17.8 x 37.3 inch(2250 x 452 x 947 mm) | 92.1 x 24.6 x 34.0 inch(2340 x 624 x 864 mm) |
| Patient positioning | Laser Localizer assisted automaticpatient table positioning.Manual Position mode | Laser Localizer assisted automaticpatient table positioning.Manual Position mode |
| Max Patient Weight | 200kg | 200kg |
| Patient-control roomcommunication | Microphones and speaker for two-way communication betweenpatient and radiologist | Microphones and speaker for two-way communication between patientand radiologist |
| Workstation | Filing Device | Predicate Device |
| Model | Multi-Processing, Multi-Core PCwith 24-inch monitor | Multi-Processing, Multi-Core PCwith 24-inch monitor |
| Memory and Capacity | 128GB of RAM, 2TB SSD Storage | 64GB of RAM, 250GB SSD Storage |
| Operating System | Microsoft Windows | Microsoft Windows |
| Receive Coils | Filing Device | Predicate Device |
| Multi-Channel Head Coil | ✓ | ✓ |
| Multi-Channel Head andneck Coil | ✓ | ✓ |
| Multi-Channel Body Coil | ✓ | ✓ |
| Multi-Channel Knee Coil | ✓ | ✓ |
| Pulse Sequences | Filing Device | Predicate Device |
| T1 Spin Echo | ✓ | ✓ |
| T1, T2 Fast Spin Echo | ✓ | ✓ |
| T1, T2* Gradient Echo | ✓ | ✓ |
| 2D Image ProcessingFeatures | Filing Device | Predicate Device |
| Image panning,zooming, windowing | ✓ | ✓ |
| Image flipping, invertingand rotation | ✓ | ✓ |
| Statistical Analysis | ✓ | ✓ |
| Geometric Measurement | ✓ | ✓ |
| Phase Image | ✓ | ✓ |
| CINE | ✓ | ✓ |
| Shutter | ✓ | ✓ |
| Image Filtering | ✓ | ✓ |
| Image Subtraction | ✓ | ✓ |
| Slice Profile | ✓ | ✓ |
| Histogram | ✓ | ✓ |
| 3D Image Processing(MPR/Max.IP) | Filing Device | Predicate Device |
| Image panning,zooming, windowing | ✓ | ✓ |
| Cutting Operation OutputStack | ✓ | ✓ |
| Image export | ✓ | ✓ |
Comparison of Technological Characteristics with the Predicate Device:
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results when using the images in medical diagnosis. The minor differences in technological characteristics do not constitute any safety and effectiveness issue, as indicated in performance data provided.
§ 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.