(84 days)
Yes
The device description and mentions of image processing explicitly state "AiCE Reconstruction Processing Unit for MR", which is a known AI-based reconstruction technology used in MRI. The predicate device also includes this technology.
No
The device is described as a "diagnostic imaging modality" used to "display anatomic structures" and provide "information that can be useful in diagnosis," which are functions of a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use as a diagnostic imaging modality" and that the "images yield information that can be useful in diagnosis."
No
The device is described as a "3 Tesla Magnetic Resonance Imaging (MRI) System" and mentions hardware components like the "Vantage Galan (Model MRT-3020)". While it includes software components like the "AiCE Reconstruction Processing Unit", it is fundamentally a hardware-based imaging system.
Based on the provided information, the Vantage Galan 3T system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is a "diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This describes an imaging system used to visualize internal structures, not a device that analyzes samples taken from the body (like blood, urine, or tissue).
- Device Description: The description confirms it's a "3 Tesla Magnetic Resonance Imaging (MRI) System." MRI is an imaging technique, not an in vitro diagnostic method.
- Mechanism of Action: The description of how MRI works (based on nuclear magnetic resonance of protons in body tissues and fluids) is consistent with an imaging modality, not an IVD.
- Input Imaging Modality: The input is "Magnetic Resonance Imaging (MRI)," which is an imaging technique.
- Performance Studies: The performance studies described involve bench testing with phantoms and imaging volunteers, focusing on image quality and accuracy of measurements within the images. This is typical for imaging devices, not IVDs which would involve testing with biological samples.
In Vitro Diagnostic (IVD) devices are defined as medical devices that are used to examine specimens, such as blood, tissue, or urine, taken from the human body to provide information for diagnosis, monitoring, or screening. The Vantage Galan 3T system does not perform this function. It creates images of the body itself.
No
The provided text does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
·Proton density (PD) (also called hydrogen density)
·Spin-lattice relaxation time (T1)
·Spin-spin relaxation time (T2)
·Flow dynamics
·Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Product codes
LNH
Device Description
The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K230355. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head or body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
4D Flow: Bench testing included velocity measurement in a phantom with known flow values. Additionally, images in volunteers demonstrated velocity stream lines.
Zoom DWI: Zoom DWI was evaluated utilizing phantom images and representative volunteer images to confirm that Zoom DWI is effective for suppressing wraparound artifacts, reducing image distortion, providing accurate ADC values.
3D-QALAS: Bench testing included scanning multiple volunteers and comparing, by three experienced reviewers, the resulting multiple weighted images on image quality metrics such as overall contrast and signal strength against reference images published in the literature.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrate that the system requirements have been met. Additionally, image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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August 20, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Canon Medical Systems Corporation % Orlando Tadeo Jr Sr. Manger, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, California 92780
Re: K241496
Trade/Device Name: Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: Mav 24, 2024 Received: May 28, 2024
Dear Orlando Tadeo Jr:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Ningzhi Li-S
for Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices
2
OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Indications for Use (Describe)
Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
·Proton density (PD) (also called hydrogen density)
·Spin-lattice relaxation time (T1)
·Spin-spin relaxation time (T2)
·Flow dynamics
·Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is in red, and the words "CANON MEDICAL SYSTEMS USA, INC." are in black. The logo is simple and clean, and it is likely used on the company's website, marketing materials, and products. The logo is a recognizable symbol of the company.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
1. CLASSIFICATION and DEVICE NAME
| Classification Name: | Magnetic Resonance Diagnostic Device |
|---|---|
| Regulation Number: | 90-LNH (Per 21 CFR § 892.1000) |
| Trade Proprietary Name: | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction |
| Processing Unit for MR | |
| Model Number: | MRT-3020 |
2. SUBMITTER'S NAME
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
3. OFFICIAL CORRESPONDENT
Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance Canon Medical Systems Corporation
4. CONTACT PERSON, U.S. AGENT and ADDRESS
Contact Person
Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 483-1551 Fax: (714) 730-1310 E-mail: otadeo@us.medical.canon
Official Correspondent/U.S. Agent
Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-7808 Fax: (714) 730-1310 E-mail: pbiggins@us.medical.canon
5
5. MANUFACTURING SITE
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- ESTABLISHMENT REGISTRATION 9614698
7. DATE PREPARED
May 24, 2024
8. DEVICE NAME
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
9. TRADE NAME
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
10. CLASSIFICATION NAME
Magnetic Resonance Diagnostic Device (MRDD)
11. CLASSIFICATION PANEL
Radiology
12. DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)
13. PRODUCT CODE
90-LNH
14. PREDICATE DEVICE
Predicate Device: Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR (K230355)
| System | Predicate Device |
|---|---|
| Vantage Galan 3T, MRT-3020, V9.0 with AiCE | |
| Reconstruction Processing Unit for MR | |
| Marketed By | Canon Medical Systems USA, Inc. |
| 510(k) Number | K230355 |
| Clearance Date | August 30, 2023 |
15. REASON FOR SUBMISSION
Modification of a cleared device
16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
6
17. DEVICE DESCRIPTION
The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K230355. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
18. SUMMARY OF CHANGE(S)
This submission is to report the following changes:
Summary of Hardware Changes:
- . Magnet: New magnet (inhouse) is applied.
- . Gradient coil: New gradient coil is applied.
- Real-time Platform: Real-time Platform is a new system architecture designed around new Real ● time Manager (RTM) and it provides stable system performance with highspeed processing by RTM.
Summary of Software Changes:
- 4D Flow: 4D Flow Application provides the function of blood flow conditions by combining with external analytical software. Quantitative analysis such as streamline, path line, and velocity is available. Moreover, either Cine or Retro can be used together in PS3D, and PS images with time-phase information can be obtained.
- Zoom DWI: Zoom DWI Application offers diffusion images of smaller FOV size by selective excitation and outer volume suppression (OVS). This application proposed to remove the distortion and the aliasing artifact in PE direction.
- . 3D-QALAS: 3D-QALAS (3D-quantification using an interleaved Look-Locker acquisition sequence with T2 preparation pulse) is a scan technique that acquires signals with FFE3D using T2prep pulse and IR pulse in combination. External analytical software is required for quantitative analysis.
Summary of Accessory Changes:
- Uninterruptible Power-supply System Kit: This option enables to protect storage such as HDDs ● and SSDs by continuing to power the HOST-PC and SERVER-PC of the MRI system in the event of a power outage.
19. SAFETY PARAMETERS
| Item | Subject Device:
Vantage Galan 3T, MRT-3020,
V10.0
with AiCE Reconstruction
Processing Unit for MR | Predicate Device:
Vantage Galan 3T, MRT-3020,
V9.0
with AiCE Reconstruction
Processing Unit for MR (K230355) | Notes |
|-----------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------|
| Static field strength | 3T | 3T | Same |
| Operational Modes | Normal and 1st Operating Mode | Normal and 1st Operating Mode | Same |
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Image /page/7/Picture/0 description: The image features the logo of Canon Medical Systems USA, Inc. The word "Canon" is displayed in a bold, red font, while the rest of the company name is in a smaller, black font. The logo is simple and clean, with a focus on the company name.
| Item | Subject Device:
Vantage Galan 3T, MRT-3020,
V10.0
with AiCE Reconstruction
Processing Unit for MR | Predicate Device:
Vantage Galan 3T, MRT-3020,
V9.0
with AiCE Reconstruction
Processing Unit for MR (K230355) | Notes |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------|
| i. Safety parameter
display | SAR, dB/dt | SAR, dB/dt | Same |
| ii. Operating mode
access requirements | Allows screen access to 1st level
operating mode | Allows screen access to 1st level
operating mode | Same |
| Maximum SAR | 4W/kg for whole body (1st
operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015) | 4W/kg for whole body (1st
operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015) | Same |
| Maximum dB/dt | 1st operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015 | 1st operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015 | Same |
| Potential emergency
condition and means
provided for shutdown | Shutdown by Emergency Ramp
Down Unit for collision hazard for
ferromagnetic objects | Shutdown by Emergency Ramp
Down Unit for collision hazard for
ferromagnetic objects | Same |
20. IMAGING PERFORMANCE PARAMETERS
No change from the previous predicate submission, K230355.
21. INDICATIONS FOR USE
Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
- Proton density (PD) (also called hydrogen density)
- Spin-lattice relaxation time (T1)
- Spin-spin relaxation time (T2)
- Flow dynamics
- Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
22. SUMMARY OF DESIGN CONTROL ACTIVITIES
Risk Management activities for this modification are included in this submission. The test methods used are the same as those submitted in the previously cleared submission of the predicate device, Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR (K230355). A declaration of conformity with design controls is included in this submission.
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Image /page/8/Picture/0 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is in red, and the rest of the text is in black. The logo is simple and professional.
Made For life
23. SAFETY
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards.
This device is based upon the same technologies, materials and software as the predicate device. Risk activities were conducted in concurrence with established medical device development standards and guidance. Additionally, testing was done in accordance with applicable recognized consensus standards published by the International Electrotechnical Commission (IEC) for medical devices and the National Electrical Manufacturers Association (NEMA):
LIST OF APPLICABLE STANDARDS
- ANSI AAMI ES60601-1:2005/(R)2012 . and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
- IEC60601-1:2005, A1:2012, A2:2020 ●
- IEC60601-1-2:2014+A1:2020
- IEC60601-1-6 (2010), Amd.1 (2013), Amd.2 (2020)
- IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015)
- IEC60825-1 (2014) ●
- IEC62304 (2006), Amd.1 (2015) ●
- IEC62366-1 (2020) ●
- ISO 10993-1 (2018) ●
- NEMA MS 1:2008 (R2020) ●
- NEMA MS 2:2008 (R2020)
- NEMA MS 3:2008 (R2020) ●
- NEMA MS 4 (2010) ●
- NEMA MS 5 (2010)
24. TESTING
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrate that the system requirements have been met. Additionally, image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria.
4D Flow: 4D Flow provides the function of visualization of blood flow conditions by combining with external analytical software. Bench testing included velocity measurement in a phantom with known flow values. Additionally, images in volunteers demonstrated velocity stream lines.
Zoom DWI: Zoom DWI offers diffusion images of smaller FOV size by selective excitation and outer volume suppression (OVS). Zoom DWI was evaluated utilizing phantom images and representative volunteer images to confirm that Zoom DWI is effective for suppressing wraparound artifacts, reducing image distortion, providing accurate ADC values.
3D-QALAS: 3D-QALAS (3D-quantification using an interleaved Look-Locker acquisition sequence with T2 preparation pulse) is a scan technique that acquires signals with FFE3D using T2prep pulse and IR pulse in combination. External analytical software is required for quantitative analysis. Bench testing included scanning multiple volunteers and comparing, by three experienced reviewers, the resulting multiple weighted images on image quality metrics such as overall contrast and signal strength against reference images published in the literature.
9
Software Documentation for a Basic Documentation Level, per the FDA guidance document, "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, is included in this submission. This documentation includes justification for the Basic Documentation Level determination as well as testing which demonstrates that the verification requirements have been met.
Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued on September 27, 2023, is also included as part of this submission.
25. SUBSTANTIAL EQUIVALENCE
Canon Medical Systems Corporation believes that the Vantage Galan 3T, MRT-3020, V10.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR, is substantially equivalent to the previously cleared predicate device referenced in this submission.
Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020, V10.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR, are substantially equivalent to the previously cleared predicate device.
26. CONCLUSION
The modifications incorporated into the Vantage Galan 3T, MRT-3020, V10.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR, do not change the indications for use or the intended use of the device. Based upon bench testing, successful completion of software validation, and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.