(32 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on hardware and established MRI technology.
No
The document states that the device is "indicated for use as a diagnostic imaging modality" and that "these images yield information that can be useful in diagnosis." It does not mention any therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Vantage Orian 1.5T systems are "indicated for use as a diagnostic imaging modality". It further elaborates that the images produced "yield information that can be useful in diagnosis" when interpreted by a trained physician.
No
The device description explicitly states it is a "1.5 Tesla Magnetic Resonance Imaging (MRI) System" and details hardware components like the magnet, gradient coil, and whole body coil. This indicates it is a hardware device with associated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vantage Orian 1.5T system is an MRI machine. Its function is to produce images of the internal structures of the body using magnetic fields and radio waves. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This is consistent with imaging, not in vitro testing.
- Device Description: The description details the physical components and technology of an MRI system, not an instrument for analyzing biological samples.
Therefore, the Vantage Orian 1.5T system is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Vantage Orian 1.5T 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 Orian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian uses 1.4 m short and 4.0 tons light weight magnet. It includes the Canon Pianissimo™ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Orian provides the maximum field of view of 55 x 50 cm. The Model MRT-1550/AS, AT, AW, AX includes the standard gradient system. This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Orian MRI System is comparable to the current 1.5T Vantage Orian MRI System (K182282), cleared October 19, 2018 with the following modifications.
Mentions image processing
Not Found
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
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)
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K191662
Trade/Device Name: Vantage Orian 1.5T, MRT-1550, V4.5 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: June 20, 2019 Received: June 21, 2019
Dear Mr. Tadeo:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
July 23, 2019
1
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
Indications for Use
510(k) Number (if known)
K191662
Device Name Vantage Orian 1.5T, MRT-1550, V4.5
Indications for Use (Describe)
Vantage Orian 1.5T 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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3
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 Orian 1.5T, MRT-1550, V4.5 |
| Model Number: | MRT-1550 |
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) 669-7459 Fax: (714) 730-1310 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 pbiggins@us.medical.canon
4
MANUFACTURING SITE
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- ESTABLISHMENT REGISTRATION
9614698
- ESTABLISHMENT REGISTRATION
-
- DATE PREPARED June 20, 2019
7. DEVICE NAME
Vantage Orian 1.5T, MRT-1550, V4.5
8. TRADE NAME
Vantage Orian 1.5T, MRT-1550, V4.5
9. CLASSIFICATION NAME
Magnetic Resonance Diagnostic Device (MRDD)
10. CLASSIFICATION PANEL
Radiology
11. DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)
12. PRODUCT CODE
90-LNH
13. PREDICATE DEVICE
| System | Predicate Device |
|---|---|
| Vantage Orian 1.5T, MRT-1550, V4.5 | |
| Marketed By | Canon Medical Systems USA |
| 510(k) Number | K182282 |
| Clearance Date | October 19, 2018 |
5
14. REASON FOR SUBMISSION
Modification of a cleared device
15. SUBMISSION TYPE
Special 510(k) Premarket Notification
16. DEVICE DESCRIPTION
The Vantage Orian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian uses 1.4 m short and 4.0 tons light weight magnet. It includes the Canon Pianissimo™ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Orian provides the maximum field of view of 55 x 50 cm. The Model MRT-1550/AS, AT, AW, AX includes the standard gradient system. This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Orian MRI System is comparable to the current 1.5T Vantage Orian MRI System (K182282), cleared October 19, 2018 with the following modifications.
17. SUMMARY OF CHANGE(S)
. Magnet (For MRT-1550/AS, MRT-1550/AT, MRT-1550/AW, MRT-1550/AX):
The Vantage Orian 1.5T Encore Program is a field upgrade program designed to utilize the currently installed 1.5T magnet (OR76) of Vantage, Atlas and Vantage Titan 1.5T systems, and convert the existing system to a Vantage Orian 1.5T MR system. The Vantage Orian 1.5T Encore Program designation will be MRT-1550/AS, AT, AW, AX.
| Orian | Orian Upgrade from Vantage/Atlas/Vantage Titan | |
|---|---|---|
| Magnet | OR200 magnet | Used OR76 magnet on site |
| (Same magnet performance as | ||
| brand-new OR76 magnet) | ||
| System label | MRT-1550/AC, MRT-1550/AD, | |
| MRT-1550/AG, MRT-1550/AH, | ||
| MRT-1550/AK, MRT-1550/AL, | ||
| MRT-1550/AO, MRT-1550/AP | ||
| (Predicate Devices) | MRT-1550/AS, MRT-1550/AT, | |
| MRT-1550/AW, MRT-1550/AX, | ||
| (Subject Devices) |
6
List of the systems with OR76 magnet which are included in the Encore Orian Program
| 510(k) number | Device name | Model Number |
|---|---|---|
| K032490 | EXCELART Vantage AGV | MRT-1503/P2 |
| EXCELART Vantage XGV | MRT-1503/P3 | |
| K060003 | EXCELART Vantage ZGV | MRT-1503/P5 |
| K063361 | EXCELART Vantage Atlas-X | MRT-1503/S3 |
| EXCELART Vantage Atlas-Z | MRT-1503/S5 | |
| K080038 | Vantage Titan | MRT-1504/S3 |
| K112003 | Vantage Titan HSR | MRT-1504/A5 |
| K120638 | Vantage Titan | MRT-1504/U4 |
| K122613 | Vantage Titan | MRT-1504/U5 |
| K150427 | Vantage Titan | MRT-1510/3A* |
*Internal documentation determined that a new 510(k) was not required to market this model number.
18. SAFETY PARAMETERS
| Item | Subject Device:
Vantage Orian 1.5T, MRT-1550,
V4.5 | Predicate Device:
Vantage Orian 1.5T, MRT-1550,
V4.5 | Notes |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------|
| Static field strength | 1.5T | 1.5T | 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) | 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 | 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 |
7
19. IMAGING PERFORMANCE PARAMETERS
No change from the previous predicate submission, K182282.
20. INDICATIONS FOR USE
Vantage Orian 1.5T 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 vield information that can be useful in diagnosis.
21. SUMMARY OF DESIGN CONTROL ACTIVITIES
Hazard analysis has been performed and documentation is included in this submission. The test methods used are the same as those submitted in the previously cleared submissions of the predicate device, Vantage Orian 1.5T, MRT-1550, V4.5 (K182282). A declaration of conformity with design controls is included in this submission.
22. 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):
8
LIST OF APPLICABLE STANDARDS
- IEC60601-1 (2005), Amd.1 (2012) ●
- IEC60601-1-2 (2014)
- IIEC60601-1-6 (2010), Amd.1 (2013)
- IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015)
- 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) ●
23. 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
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.
24. SUBSTANTIAL EQUIVALENCE
Canon Medical Systems Corporation believes that the Vantage Orian 1.5T, MRT-1550, V4.5 Magnetic Resonance Imaging (MRI) System 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 Orian 1.5T, MRT-1550, V4.5 are substantially equivalent to the previously cleared predicate devices.
25. CONCLUSION
The modifications incorporated into the Vantage Orian 1.5T, MRT-1550, V4.5 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.