(15 days)
No
The document describes a standard MRI system with hardware modifications and noise reduction technology. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections.
No
The device is an imaging system (MRI) used for diagnosis and visualization, not for treating or rehabilitating medical conditions.
Yes.
The device's "Intended Use / Indications for Use" section explicitly lists various imaging applications (e.g., MRCP, MR Urography, MR Angiography, BOLD imaging, Perfusion/Diffusion Imaging, Proton Spectroscopy) that are used to diagnose medical conditions, and it is a Magnetic Resonance Imaging (MRI) System, which is a common diagnostic tool.
No
The device description clearly states it is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, which is a hardware device. The modifications listed are also hardware components (gantry bore, RF amplifier, gradient power supply, transformer cabinet).
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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a Magnetic Resonance Imaging (MRI) system. MRI is an in vivo imaging modality, meaning it creates images of the inside of the body without taking samples.
- Intended Use: The intended use clearly states "Imaging of: - The Whole Body..." and lists various anatomical sites and imaging techniques, all of which are performed directly on the patient.
Therefore, based on the provided information, the Vantage Titan MRI System is an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Imaging of:
- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, 0 neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.]
- Fluid Visualization
- 2D / 3D Imaging
- MR Angiography / MR Vascular Imaging
- Blood Oxygenation Level Dependent (BOLD) imaging
- Perfusion / Diffusion Imaging G
- . Proton Spectroscopy
Product codes
LNH
Device Description
The Vantage Titan (Model MRT 1504/S3) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses the same magnet as the other Vantage MRJ Systems. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology), and has a 1.4 m short magnet. The design of the gradient coil and the WB coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm.
The Vantage Titan MRI System is comparable to the current EXCELART Vantage Atlas-X MRI System (K063361), cleared November 21, 2006 with the following modifications.
- Gantry bore diameter has been increased from 600mm to 690mm at bore center.
- Maximum power of RF amplifier has been increased from 20KW to 35KW.
- RF amplifier cabinet has been added.
- Gradient power supply has been modified to increase the output current from 300A to 550A.
- Transformer cabinet has been modified to cover the system power requirement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, 0 neck, TMJ, heart, blood vessels)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Not Found
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
Toshiba America Medical Systems, Inc.
K080038
pg 1 of 3
510(k) Premarket Notification
Vantage Titan
TM
JAN 22 2008
510(k) SUMMARY
- DEVICE NAME:
Model Name:
Trade/Proprietary Name:
Magnetic Resonance Diagnostic Device Accessory MRT-1504/S3 Vantage Titan
2. ESTABLISHMENT REGISTRATION: 2020563
| 3. U.S. Agent Name and Address: | Toshiba America Medical Systems, Inc.
2441 Michelle Drive
Tustin, Ca 92780 |
|---------------------------------|----------------------------------------------------------------------------------|
| Contact Person: | Paul Biggins
(714) 730 - 5000 |
TOSHIBA CORPORATION MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
5. DATE OF SUBMISSION: December 19, 2007
6. DEVICE DESCRIPTION
Manufacturing Site:
The Vantage Titan (Model MRT 1504/S3) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses the same magnet as the other Vantage MRJ Systems. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology), and has a 1.4 m short magnet. The design of the gradient coil and the WB coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm.
The Vantage Titan MRI System is comparable to the current EXCELART Vantage Atlas-X MRI System (K063361), cleared November 21, 2006 with the following modifications.
- · Gantry bore diameter has been increased from 600mm to 690mm at bore center.
- · Maximum power of RF amplifier has been increased from 20KW to 35KW.
- · RF amplifier cabinet has been added.
- · Gradient power supply has been modified to increase the output current from 300A to 550A.
- · Transformer cabinet has been modified to cover the system power requirement.
1
K080038
pg. 2 of 3
Toshiba America Medical Systems, Inc.
510(k) Premarket Notification Vantage TitanTM
6.1. SUMMARY OF MAJOR HARDWARE CHANGES
- a. Gradient coil has been modified to increased the inside diameter.
- b. WB coil has been modified to increased the inside diameter.
- Maximum power of RF amplifier has been increased from 20KW to 35KW. C.
- d. RF amplifier cabinet has been added.
- Gradient power supply has been modified to increase the output current from 300A to e. 550A.
- f. Transformer cabinet has been modified to cover the system power requirement.
SUMMARY OF MAJOR SOFTWARE CHANGES 6.2.
- a. New RF amplifier cabinet control.
- b. New gradient power supply control.
- C. Add the over temperature protection inside the gantry bore.
- d. Modified the data base for distortion correction for new gradient coil.
- e. Modified the data base for SAR control for new WB coil.
| | Current EXCELART Vantage
Atlas-X (No changes from the
previous submission, K063361 ) | New Vantage Titan |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------|
| a. Static field strength: | 1.5 T | Same |
| b. Peak and A-weighted acoustic
noise: | 110 dB (A-weighted) | Same |
| c. Operational modes: | 1st operating mode for dB/dt and
SAR | Same |
| i. Safety parameter display: | SAR, dB/dt | Same |
| ii. Operating mode access
requirements: | Allows access to 1st level operating
mode | Same |
| d. Maximum SAR | 4W/kg for whole body (1st
operating mode specified in IEC
60601-2-33 (2002)) | Same |
| f. Maximum dB/dt |