(40 days)
Not Found
Yes
The document explicitly mentions "AiCE Reconstruction Processing Unit for MR" and states that the predicate device also includes this unit. The "AiCE" likely stands for Artificial intelligence-based image reconstruction, which is a common application of AI/ML in medical imaging.
No.
The device is indicated for use as a diagnostic imaging modality that produces images useful in diagnosis, not for therapeutic purposes.
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. While it includes software components like "AiCE Reconstruction Processing Unit," the core device is a physical MRI machine.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Vantage Galan 3T system produces images of the head or body directly, not from samples taken from the body.
- IVDs are used to provide information about a physiological or pathological state. While the images produced by this MRI system are used by a trained physician for diagnosis, the device itself is an imaging modality that visualizes anatomical structures and their properties (like proton density, relaxation times, and flow dynamics). It doesn't directly analyze biological samples to determine a physiological or pathological state in the way an IVD would (e.g., a blood test for glucose levels or a urine test for infection).
The device is a diagnostic imaging system, which is a different category of medical device than an IVD.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.
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-30200) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K203323. 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
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Mentions AI, DNN, or ML
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
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
Human observer study of Compressed SPEEDER (2D) with acceleration factors of 2.5, 3.0 and 4.0 was conducted with three board certified radiologists per anatomy, thirty two studies, and one hundred and sixteen scans that demonstrated no clinically-relevant difference in preference between the predicate Compressed SPEEDER (2D) images with acceleration factor of 2.5 when compared to the higher acceleration factor (shorter scan time) images.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Human observer study of Compressed SPEEDER (2D) with acceleration factors of 2.5, 3.0 and 4.0 was conducted with three board certified radiologists per anatomy, thirty two studies, and one hundred and sixteen scans that demonstrated no clinically-relevant difference in preference between the predicate Compressed SPEEDER (2D) images with acceleration factor of 2.5 when compared to the higher acceleration factor (shorter scan time) images. The results of the testing demonstrated that Compressed SPEEDER (2D) with the acceleration factors of 2.5, 3.0 and 4.0 performed at the equivalent performance level to the commercially available predicate device and all images with each acceleration factor are diagnostic.
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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Image /page/0/Picture/10 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, 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.
Canon Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Canon Medical Systems USA, INC. 2441 Michelle Drive TUSTIN CA 92780
Re: K211037
Trade/Device Name: Vantage Galan 3T, MRT-3020, V6.0 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: April 5, 2021 Received: April 7, 2021
Dear Ms. 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/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
May 17, 2021
1
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Vantage Galan 3T, MRT-3020, V6.0, 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) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/3 description: The image shows the logo for Canon Medical Systems USA, INC. The word "Canon" is written in red, while the rest of the text is in black. The text is left-aligned and appears to be professionally designed. The logo is simple and clean, with a focus on the company name.
Made For life
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, V6.0 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
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
ICAL SYSTEMS USA, INC.
Made For life
-
- MANUFACTURING SITE
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
- MANUFACTURING SITE
-
- ESTABLISHMENT REGISTRATION 9614698
7. DATE PREPARED
April 5th, 2021
8. DEVICE NAME
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
9. TRADE NAME
Vantage Galan 3T, MRT-3020, V6.0 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 (system): Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K203323)
TABLE No. 1: Predicate Device
| Subject Device | Predicate Device | |
|---|---|---|
| System | Vantage Galan 3T, MRT-3020, V6.0 with | |
| AiCE Reconstruction Processing Unit for MR | Vantage Galan 3T, MRT-3020, V6.0 with | |
| AiCE Reconstruction Processing Unit for MR | ||
| Marketed By | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. |
| 510(k) Number | This Submission | K203323 |
| Clearance Date | March 4th, 2021 |
15. REASON FOR SUBMISSION
Extension of the Compressed SPEEDER (2D) maximum acceleration factor of up to 4 with no changes to the cleared software and hardware.
2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968 https://us.medical.canon
5
CAL SYSTEMS USA, INC.
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16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
17. DEVICE DESCRIPTION
The Vantage Galan (Model MRT-30200) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K203323. 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)
Extension of the Compressed SPEEDER (2D) maximum acceleration factor:
| Subject Device | Predicate Device (K203323) |
|---|---|
| Up to 4 | Up to 2.5 |
19. SAFETY PARAMETERS (unchanged)
| Item | Subject Device:
Vantage Galan 3T, MRT-3020, V6.0,
with AiCE Reconstruction Processing
Unit for MR | Predicate Device:
Vantage Galan 3T, MRT-3020, V6.0,
with AiCE Reconstruction Processing
Unit for MR (K203323) | 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+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, K203323.
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.
2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968 https://us.medical.canon
6
Image /page/6/Picture/3 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is in large, bold, red letters. Below it, in smaller, black letters, is the text "CANON MEDICAL SYSTEMS USA, INC."
Made For life
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
No change from the previous predicate submission, K203323. 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 submission is a modification that extends the maximum acceleration factor of Compressed SPEEDER (2D). There are no changes to the software and hardware from the previous Pre-Market Notification 510(k) K203323.
24. TESTING
Human observer study of Compressed SPEEDER (2D) with acceleration factors of 2.5, 3.0 and 4.0 was conducted with three board certified radiologists per anatomy, thirty two studies, and one hundred and sixteen scans that demonstrated no clinically-relevant difference in preference between the predicate Compressed SPEEDER (2D) images with acceleration factor of 2.5 when compared to the higher acceleration factor (shorter scan time) images. The results of the testing demonstrated that Compressed SPEEDER (2D) with the acceleration factors of 2.5, 3.0 and 4.0 performed at the equivalent performance level to the commercially available predicate device and all images with each acceleration factor are diagnostic.
25. SUBSTANTIAL EQUIVALENCE
Canon Medical Systems Corporation believes that the Vantage Galan 3T, MRT-3020, V6.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR is substantially equivalent to the previously cleared predicate device, Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR, as there is no change to the hardware and software of the predicate device. Additionally, the testing conducted demonstrates that the device performance is equivalent to the predicate device for the Compressed SPEEDER (2D) acceleration factors that are stated above.
26. CONCLUSION
The Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR does not have any change for the indications for use or the intended use of the device. Bench testing and volunteer clinical imaging additionally conducted does not change the conclusion that the subject device is safe and effective for its intended use.