(108 days)
Not Found
No
The document describes a standard MRI system and its features, with no mention of AI or ML technologies for image analysis, processing, or any other function.
No
Explanation: The device is described as "a diagnostic imaging modality" and its purpose is to "yield information that can be useful in diagnosis," not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use as a diagnostic imaging modality" and that "these images yield information that can be useful in diagnosis."
No
The device description clearly states it is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, which is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- Vantage Elan Function: The Vantage Elan is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structures of the body in vivo (within the living organism) using magnetic fields and radio waves. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it produces images of anatomic structures of the head or body for diagnostic imaging. This is consistent with an imaging device, not an IVD.
Therefore, based on the provided information, the Vantage Elan system is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Vantage Elan 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
Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Product codes
LNH
Device Description
The Vantage Elan (Model MRT-2020) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Elan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™Σ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Elan provides the maximum field of view of 55 x 50 cm. The Model MRT-2020/A1 is without secondary cooling system and the Model MRT-2020/A2 is with secondary cooling system. The Vantage Elan MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 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)
Clinical image validation was conducted using volunteers to verify image quality and functionality of the system.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2014
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs/U.S. Agent Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K141472
Trade/Device Name: Vantage Elan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 20, 2014 Received: August 21, 2014
Dear Mr. Biggins:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
MRT-2020; Vantage Elan
Indications for Use (Describe)
Vantage Elan 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
Contrast agent use is restricted to the approved drug indications. 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY AND EFFECTIVENESS
1. CLASSIFICATION and DEVICE NAME:
| Classification Name: | Magnetic Resonance Diagnostic Device |
|---|---|
| Regulation Number: | 90-LNH (Per 21 CFR 892.1000) |
| Trade Proprietary Name: | Vantage Elan |
| Model Number: | MRT-2020 |
2. ESTABLISHMENT REGISTRATION: 9614698
-
- Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
4. CONTACT PERSON, U.S AGENT and ADDRESS:
U.S. Agent Name: Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780 Tel. (714) 669-7808
5. MANUFACTURING SITE:
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
6. DATE OF SUBMISSION:
May 30, 2014
7. DEVICE DESCRIPTION:
The Vantage Elan (Model MRT-2020) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Elan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™Σ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Elan provides the maximum field of view of 55 x 50 cm. The Model MRT-2020/A1 is without secondary cooling system and the Model MRT-2020/A2 is with secondary cooling system. The Vantage Elan MRI System
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is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.
6.1 SUMMARY OF HARDWARE CHANGES
- a. Main magnet has been changed from OR76 to TN150.
- b. Maximum power of RF amplifier has been decreased from 20kW to 12kW.
- c. Maximum Gradient field strength has been changed from 34mT/m to 33mT/m.
d. Maximum Slew Rate of gradient field has been changed from 148mT/m/ms to 125mT/m/ms.
e. Patient aperture size has been changed from 71cm to 63cm.
f. Number of units has been reduced from 7 to 5.
g. Optical transmission of MR signals from gantry to main cabinet.
6.2 SUMMARY OF SOFTWARE CHANGES
- a. SpineLine (automatic positioning assistance for spine)
- b. 2D RMC (2D Real-time motion correction)
- c. New operating system (Windows 7)
d. ECG, peripheral pulse, and respiratory gating waveforms are displayed on the LCD monitor of console.
e. Control for new hardware
| Item | Vantage Elan (subject device) | Vantage Titan K120638 (Predicate Device) | Notes |
|---|---|---|---|
| Static field strength | 1.5T | 1.5T | Same |
| Operational Modes | 1st Operating Mode | 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)) | 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33(2002)) | Change* |
| Maximum dB/dt |