(142 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional MRI technology and noise reduction.
No
The device is described as a diagnostic imaging modality that produces images useful in diagnosis, not for treating conditions.
Yes
The MRI system is explicitly stated as "indicated for use as a diagnostic imaging modality."
No
The device description clearly states it is a "1.5 Tesla Magnetic Resonance Imaging (MRI) System," which is a hardware device.
Based on the provided information, 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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that this is an MRI system. MRI is an imaging modality that produces images of the inside of the body using magnetic fields and radio waves. It does not involve testing samples taken from the body.
- Intended Use: The intended use is to produce images of anatomical structures of the head or body for diagnostic purposes. This is consistent with in-vivo imaging, not in-vitro testing.
Therefore, the Vantage Titan HSR MRI system is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MRI system is 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. In addition, this system supports non-contrast 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 Titan HSR (Model MRT-1504/A5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan HSR uses the same magnet as the existing Vantage Titan (K080038). It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan HSR provides the maximum field of view of 55 x 55 x 55 cm.
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
human volunteer studies (in Japan) were conducted to verify imaging performance.
Key Metrics
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. Pre-Market Notification 510(k) Vantage Titan HSR, MRT-1504/A5
510(k) SUMMARY AND EFFECTIVENESS
1. DEVICE NAME:
| Generic Name: | Magnetic Resonance Diagnostic Device |
|---|---|
| Model Name: | MRT-1504/A5 |
| Trade/ Proprietary Name: | Vantage Titan HSR |
2. ESTABLISHMENT REGISTRATION: 2020563
3. U.S AGENT INFORMATION:
| U.S. Agent Name: | Paul Biggins
(714) 730-5000 |
|---------------------------------|-----------------------------------------------------------------------------------------------------|
| Establishment Name and Address: | Toshiba America Medical Systems, Inc.
2441 Michelle Drive
Tustin, Ca. 92780 |
| 4. MANUFACTURING SITE: | Toshiba Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi 324-8550
Japan |
| 5. DATE OF SUBMISSION: | November 14, 2011 |
6. DEVICE DESCRIPTION:
The Vantage Titan HSR (Model MRT-1504/A5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan HSR uses the same magnet as the existing Vantage Titan (K080038). It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan HSR provides the maximum field of view of 55 x 55 x 55 cm.
7. SUMMARY OF MAJOR HARDWARE CHANGES
- a. New Gradient amplifier
- b. New Gradient coil
- c. Wireless gating unit is added (optional)
Page 1 of 4
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8. SUMMARY OF MAJOR SOFTWARE CHANGES
- a. New Software platform
- b. Modified the data base for distribution correction and dB/dt calculation for new gradient coil.
9. SAFETY PARAMETERS
| Item | New Vantage Titan HSR
(Subject device) | EXCELART Vantage
Titan , K080038
(Predicate Device) | Notes |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------|
| Static field strength | 1.5T | 1.5T | Same |
| Peak and A-
weighted acoustic
noise | 113.0 dB (A-weighted)
121.6 dB (peak) | 105.7 dB (A-weighted)
115.7dB (peak) | 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(2002)) | 4W/kg for whole body (1st
operating mode specified
in
IEC 60601-2-33(2002)) | Same |
| Maximum dB/dt |