(57 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 intended use of the device is described as a "diagnostic imaging modality" to produce images that are "useful in diagnosis," rather than for treating or curing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use as a diagnostic imaging modality" and that, when interpreted, the images "yield information that can be useful in diagnosis."
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-based medical device, not software-only.
Based on the provided information, the Vantage Orian 1.5T system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Vantage Orian Function: The Vantage Orian is a Magnetic Resonance Imaging (MRI) system. Its intended use is to produce images of the internal structures of the head or body using magnetic fields and radio waves. It does not involve the analysis of specimens taken from the body.
- Intended Use/Indications for Use: The description clearly states it's a "diagnostic imaging modality" that produces images of "anatomic structures of the head or body." This aligns with in vivo imaging, not in vitro diagnostics.
- Device Description: The description details the physical components of an MRI machine (magnet, coils, etc.), not equipment for handling or analyzing biological specimens.
Therefore, the Vantage Orian 1.5T system falls under the category of medical imaging devices rather than In Vitro Diagnostic devices.
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 3.8 tons light 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 55 x 50 cm. The Model MRT-1550/AC, AD, AG, AH includes the standard gradient system and Model MRT-2020/AK, AL, AO, AP includes the XGO 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 Titan MRI System (K170412), cleared June 7, 2017 with the following modifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI (Magnetic Resonance Imaging)
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
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. A volunteer study was conducted to evaluate the established PNS limits. Sample clinical images were included in the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 19, 2018
Canon Medical Systems Corporation % Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN, CALIFORNIA 92780
Re: K182282
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: August 21, 2018 Received: August 23, 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 mav, 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 avare 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
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.
510(k) Number (if known)
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) |
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."
3
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
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
4
-
- MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED August 21, 2018
-
- DEVICE NAME Vantage Orian 1.5T, MRT-1550, V4.5
-
- TRADE NAME Vantage Orian 1.5T, MRT-1550, V4.5
10. CLASSIFICATION NAME
Magnetic Resonance Diagnostic Device (MRDD)
11. CLASSIFICATION PANEL
Radiology
-
- DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)
- DEVICE CLASSIFICATION
-
- PRODUCT CODE
90-LNH
- PRODUCT CODE
14. PREDICATE DEVICE
Primary Predicate Device (system): Vantage Titan 1.5T, MRT-1510, M-Power GX (K170412) Reference Predicate Device (software/sequences): Vantage Galan 3T, MRT-3020, V5.0 (K181593)
| System | Subject | Primary Predicate Device | Reference Predicate Device |
|---|---|---|---|
| Vantage Orian, MRT-1550, | |||
| V4.5 | Vantage Titan 1.5T, MRT- | ||
| 1510, M-Power GX | Vantage Galan 3T, MRT-3020, | ||
| V5.0 | |||
| Marketed By | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. |
| 510(k) | This Submission | K170412 | K181593 |
| Clearance | June 7th, 2017 | August 13th, 2018 |
15. REASON FOR SUBMISSION
New medical device
5
16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
17. 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 3.8 tons light 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 55 x 50 cm. The Model MRT-1550/AC, AD, AG, AH includes the standard gradient system and Model MRT-2020/AK, AL, AO, AP includes the XGO 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 Titan MRI System (K170412), cleared June 7, 2017 with the following modifications.
18. SUMMARY OF CHANGE(S)
This submission is to report the following changes:
Summary of Hardware Changes:
- New Cover Design ●
- Optional Dockable/Detachable Table ●
- RF System: ●
- o Number of transmission channel was changed from 1ch to 2ch
- o Maximum power of RF amplifier was changed from 20kW(1ch) to 30kW(2ch)
- Maximum gradient amplitude (per axis) in T/m, rise time (ms), and maximum slew rate (T/m/s) changes:
| System | Vantage Orian 1.5T, MRT-1550, V4.5
Subject Device | | Vantage Titan 1.5T, MRT-1510, M-Power GX
Predicate Device
K170412 |
|-------------------------------|----------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------------|
| Model | MRT-1550/AC
MRT-1550/AD
MRT-1550/AG
MRT-1550/AH | MRT-1550/AK
MRT-1550/AL
MRT-1550/AO
MRT-1550/AP | MRT-1510 |
| Maximum Gradient
Amplitude | 34mT/m | 45 mT/m | 34mT/m |
| Rise time | 0.220 ms | 0.225 ms | 0.230 ms |
| Maximum Slew Rate | 155T/m/s | 200T/m/s | 148T/m/s |
- Increase Gradient Strength: increased gradient strength of 45mT/m for models MRT-O 1550/AK, MRT-1550/AL, MRT-1550/AO, MRT-1550/AP
- Maximum Slew Rate Change: maximum slew rate of gradient field was changed from o 148mT/m/ms to:
- 155 mT/m/ms for MRT-1550/AC, MRT-1550/AD, MRT-1550/AG, MRT-1550/AH I
- 200 mT/m/ms for MRT-1550/AK, MRT-1550/AL, MRT-1550/AO, MRT-1550/AP I
6
Made For life
- Rise Time Change: rise time changed from 0.230 ms to:
- 0.22 ms for MRT-1550/AC, MRT-1550/AD, MRT-1550/AG, MRT-1550/AH I
- I 0.225 ms for MRT-1550/AK, MRT-1550/AL, MRT-1550/AO, MRT-1550/AP
Summary of Software Changes:
- Additional Software Functionalities and Improvements:
- New SAR: New calculation method is applied. O
- DSD (Dynamic Shrinkage Denoise) Filter: The DSD (Dynamic Shrinkage Denoise) Filter O noise removal technique is based on principal component analysis and shrinkage. Components determined to be noise are removed, making it possible to provide images with optimal smoothness and sharpness at the same time.
- MultiBand SPEEDER: MultiBand SPEEDER is a technique to acquire multiple slices at o one time by using simultaneous multiband excitation RF pulses. MultiBand SPEEDER technique can be used to reduce acquisition time.
- O 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 O 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 plane of 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 O 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 O 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 O determined. If the R-R intervals at the time of data acquisition is out of range, data acquisition is performed again.
- SpineLine+ (Spinal Scan Positioning Support Function): provides automatic positioning O assistance for spine imaging. SpineLine was previously cleared under K152371. As compared to SpineLine, SpineLine+ offers improved detection of the axial plane along the intervertebral space.
- Sequence Enhancements:
- O WFS DIXON (Water Fat Separation): WFS option previously applicable to FE3D sequences is added to FSE2D sequences.
7
- 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.
- o Fast 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.
- 2D-RMC (Real Time Motion Correction) for EPI: 2D Real-time Motion Correction is O available for Diffusion Weighted Imaging to mitigate respiratory motion artifacts during abdominal examinations. 2D-RMC option is newly applied to EPI sequences (previously applicable to FASE3D and FFE3D).
19. SAFETY PARAMETERS
| Item | Subject Device:
Vantage Orian 1.5T, MRT-1550,
V4.5 | Predicate Device:
Vantage Titan 1.5T, MRT-1550, M-
Power GX (K170412) | 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) | 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, K170412.
8
21. 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.
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 submissions Vantage Titan 1.5T, MRT-1510, M-Power GX (K170412) and the Vantage Galan 3T, MRT-3020, V5.0 (K181593). 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) ●
9
24. TESTING
This submission contains test data that demonstrates the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and in accordance with the FDA Guidance, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issues on November 18, 2016.
Risk analysis and verification/validation testing, conducted through bench testing, are included in this submission which demonstrate that the system requirements have been met. A volunteer study was conducted to evaluate the established PNS limits. Sample clinical images were included in the determination of substantial equivalence.
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 Orian 1.5T, MRT-1550, V4.5 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Titan 1.5T, MRT-1550, M-Power GX (K170412), 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 device.
26. CONCLUSION
The modifications incorporated into the Vantage Orian 1.5T, MRT-1550, V4.5 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.