(56 days)
Not Found
No
The document describes a standard MRI system and its intended use, focusing on image acquisition and display based on physical principles. There is no mention of AI, ML, or related concepts in the provided text.
No.
The device is indicated for use as a "diagnostic imaging modality" to produce images for "diagnosis", not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is a "diagnostic imaging modality" and that the images "yield information that can be useful in diagnosis."
No
The device description explicitly states it is a "3 Tesla Magnetic Resonance Imaging (MRI) System," which is a hardware device. The summary also mentions bench testing, phantom imaging, and volunteer clinical imaging, which are typical performance studies for hardware-based imaging systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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) to diagnose a condition.
- 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 test.
- Mechanism: The description explains that the images are based on the "spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR)." This is the principle of MRI, which is a non-invasive imaging method.
- Interpretation: The information states that the images are "interpreted by a trained physician," which is typical for medical imaging. IVD results are often interpreted in conjunction with clinical information, but the primary function of an IVD is the analysis of a biological sample.
In vitro diagnostics (IVDs) are medical devices that are used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests. It creates images of the body itself.
N/A
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 (comma separated list FDA assigned to the subject device)
LNH
Device Description
The Vantage Galan (Model MRT-3020/A7) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K173382. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
Mentions image processing
- KneeLine+: When the basic planes of the knee are to be scanned, this application makes it possible to set the slice plane more easily than before. After a 3D image is acquired, it is used to obtain the three planes (sagittal, axial and coronal) after adjusting the angle of the knee. The obtained images can be used to set the positioning ROI. If necessary, the orientation and position of the detected basic planes can be adjusted by scan positioning operation in the Scan Plan (Locator) window.
- k-t SPEEDER: Estimated sensitivity data is calculated using the sensitivity data for each coil obtained during scanning, and the folded image obtained by skipped image acquisition is unfolded. A speedup factor of 2 to 8 can be achieved depending on the skipping ratio.
- R-wave Monitoring: The range of the R-R intervals for data acquisition can be determined. If the R-R intervals at the time of data acquisition is out of range, data acquisition is performed again.
- SpineLine+: New spinal plane detection algorithm improves detection rate for patients.
- Sequence Enhancements:
- o WFS DIXON (Water Fat Separation): WFS option previously applicable to FE3D sequences is added to FSE2D sequences.
- o Quick Star: Data acquisition is started from the center of the k-space in a radial pattern in the in-plane direction in the k-space and in a Cartesian pattern in the slice direction. Because the data near the center of the k-space is acquired repeatedly, data acquisition with Quick Star is relatively unaffected by motion.
- oFast 3D Mode: Fast 3D mode can be used to increase imaging efficiency. Two types of Fast 3D mode (Multiple and Wheel) are available. Multiple is technique for acquiring two parallel SE lines continuously in a single shot. Wheel is technique for acquiring signals at the center of the k-space in a deformed wheel pattern in the PE-SE plane.
- o 2D-RMC (Real-time Motion Correction) for EPI: 2D Real-time Motion Correction is available for Diffusion Weighted Imaging to mitigate respiratory motion artifacts of abdominal examination. 2D-RMC option previously applicable to FASE3D and FFE3D sequences is added to EPI sequences.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head or body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
When interpreted by a trained physician
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Canon Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Toshiba America Medical System, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K181593
Trade/Device Name: Vantage Galan 3T, MRT-3020/A7, V5.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 15, 2018 Received: June 18, 2018
Dear Janine Reyes:
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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
August 13, 2018
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Device Name
Vantage Galan 3T, MRT-3020/A7, V5.0
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) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/3 description: The image displays the logo of Canon Medical Systems USA, Inc. The word "Canon" is written in a bold, red font, while the text "CANON MEDICAL SYSTEMS USA, INC." is written in a smaller, black font below the Canon logo. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.
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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/A7, V5.0 |
| Model Number: | MRT-3020/A7 |
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
Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 E-mail: jfreyes@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
2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968 https://us.medical.canon
4
DICAL SYSTEMS USA, INC.
Made For life
-
- MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED June 15th, 2018
-
- DEVICE NAME Vantage Galan 3T, MRT-3020/A7, V5.0
-
- TRADE NAME
Vantage Galan 3T, MRT-3020/A7, V5.0
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 (system): Vantage Galan 3T, MRT-3020, V4.6
| System | Subject | Predicate Device |
|---|---|---|
| Vantage Galan 3T, MRT-3020/A7, V5.0 | Vantage Galan 3T, MRT-3020, V4.6 | |
| Marketed By | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. |
| 510(k) Number | This Submission | K173382 |
| Clearance Date | January 26, 2018 |
15. REASON FOR SUBMISSION
Modification of a cleared device
16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968 https://us.medical.canon
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Image /page/5/Picture/3 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 text is aligned to the left.
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17. DEVICE DESCRIPTION
The Vantage Galan (Model MRT-3020/A7) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K173382. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display cross-sectional 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 software functionalities have been added:
- Software change from V4.6 to V5.0 ●
- Limited Scan Mode: Operator can set SAR operating mode and upper limit of B1+rms. Scan parameters are calculated so that SAR and B1+rms do not exceed set limits.
- KneeLine+: When the basic planes of the knee are to be scanned, this application makes it possible to set the slice plane more easily than before. After a 3D image is acquired, it is used to obtain the three planes (sagittal, axial and coronal) after adjusting the angle of the knee. The obtained images can be used to set the positioning ROI. If necessary, the orientation and position of the detected basic planes can be adjusted by scan positioning operation in the Scan Plan (Locator) window.
- surevol Knee: Using a 3D image as an input, the region of the knee is determined and the ● VOI for shimming scan, map scan, or presaturation is detected. The detected VOI can be used for knee scan positioning. If necessary, the VOI can be checked and the orientation and position of the VOI can be adjusted in the Scan Plan (Locator) window.
- k-t SPEEDER: Estimated sensitivity data is calculated using the sensitivity data for each coil obtained during scanning, and the folded image obtained by skipped image acquisition is unfolded. A speedup factor of 2 to 8 can be achieved depending on the skipping ratio.
- R-wave Monitoring: The range of the R-R intervals for data acquisition can be determined. If the R-R intervals at the time of data acquisition is out of range, data acquisition is performed again.
- SpineLine+: New spinal plane detection algorithm improves detection rate for patients.
- Sequence Enhancements:
- o WFS DIXON (Water Fat Separation): WFS option previously applicable to FE3D sequences is added to FSE2D sequences.
- o Quick Star: Data acquisition is started from the center of the k-space in a radial pattern in the in-plane direction in the k-space and in a Cartesian pattern in the slice direction. Because the data near the center of the k-space is acquired repeatedly, data acquisition with Quick Star is relatively unaffected by motion.
- oFast 3D Mode: Fast 3D mode can be used to increase imaging efficiency. Two types of Fast 3D mode (Multiple and Wheel) are available. Multiple is technique for acquiring two parallel SE lines continuously in a single shot. Wheel is technique for
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Image /page/6/Picture/3 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is in a large, red, bold font. Below that, the words "CANON MEDICAL SYSTEMS USA, INC." are in a smaller, black font.
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acquiring signals at the center of the k-space in a deformed wheel pattern in the PE-SE plane.
- o 2D-RMC (Real-time Motion Correction) for EPI: 2D Real-time Motion Correction is available for Diffusion Weighted Imaging to mitigate respiratory motion artifacts of abdominal examination. 2D-RMC option previously applicable to FASE3D and FFE3D sequences is added to EPI sequences.
19. SAFETY PARAMETERS
| Item | Subject Device:
Vantage Galan 3T,
MRT-3020/A7, V5.0 | Predicate Device:
Vantage Galan 3T,
MRT-3020, V4.6 | Notes |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------|
| Static field strength | 3T | 3T | Same |
| Operational Modes | Normal and 1st Operating Mode | Normal and 1st Operating Mode | Same |
| 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) | 4W/kg for whole body (1st operating
mode specified in IEC 60601-2-33:
2010 +A1:2013) | Same |
| Maximum dB/dt | 1st operating mode specified in IEC
60601-2-33: 2010 +A1:2013 | 1st operating mode specified in IEC
60601-2-33: 2010 +A1:2013 | 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, K173382.
21. 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)
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Image /page/7/Picture/3 description: The image shows the logo for Canon Medical Systems USA, INC. The word "Canon" is written in red, and the words "CANON MEDICAL SYSTEMS USA, INC." are written in black below the word "Canon". The logo is simple and professional.
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- 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.
*NOTE: No changes to the previously cleared indication, K173382
22. SUMMARY OF DESIGN CONTROL ACTIVITIES
Risk Management activities for new software functionalities and pulse sequences 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, V4.6 (K173382). A declaration of conformity with design controls is included in this submission.
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
- IEC60601-1 (2005), Amd.1 (2012)
- IEC60601-1-2 (2007)
- IEC60601-1-8 (2006), Amd.1 (2012)
- IEC60601-2-33 (2010), Amd.1 (2013) ●
- IEC60825-1 (2007) ●
- IEC62304 (2006)
- IEC62366 (2007), Amd.1 (2014) ●
- NEMA MS 1 (2008) ●
- NEMA MS 2 (2008) ●
- NEMA MS 3 (2008) ●
- NEMA MS 4 (2010) ●
- NEMA MS 5 (2010)
24. TESTING
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
25. SUBSTANTIAL EQUIVALENCE
Canon Medical Systems Corporation believes that the Vantage Galan 3T, MRT-3020/A7, V5.0 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Galan 3T, MRT-3020, V4.6, referenced in this submission. Canon Medical
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Image /page/8/Picture/3 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 text is aligned to the left.
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Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020/A7, V5.0 are substantially equivalent to the previously cleared predicate device.
26. CONCLUSION
The modifications incorporated into the Vantage Galan 3T, MRT-3020/A7, V5.0 software do not change the indications for use or the intended use of the device. Based upon bench testing, phantom imaging, volunteer clinical imaging, 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.