(92 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on hardware and software modifications without indicating AI/ML capabilities.
No.
The MRI system is indicated for use as a diagnostic imaging modality to produce images for diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MRI system is "indicated for use as a diagnostic imaging modality".
No
The device description explicitly mentions hardware components like a magnet, gradient strength, magnet cover, and cabinet configuration changes, indicating it is a physical MRI system with accompanying software, not a software-only 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.
- Device Function: The description clearly states that the MRI system is a diagnostic imaging modality that produces images of the head or body. It works by utilizing the nuclear magnetic resonance properties of protons within the body.
- No Sample Analysis: The device does not analyze samples taken from the body. It directly images the internal structures of the body.
Therefore, the function and mechanism of this MRI system fall under the category of in vivo diagnostic imaging, not in vitro diagnostics.
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 new Vantage Titan (Model MRT-1504/U4) MRI System is comparable to the current 1.5T Vantage Titan MRI System. The Vantage Titan uses the same magnet as the current Vantage Titan (K080038). However, the following modifications have been added: a redefinition of gradient strength, magnet cover and cabinet's configuration changes. In addition, two applications software: Diffusion Tensor Tractography (DTT), and PaceMaker.
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)
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN - 1 2012
K12D 638
Toshiba America Medical Systems, Inc Pre-Market Notification 510(k) Vantage Titan, v2.1, MRT-1504/U4
510(k) SUMMARY AND EFFECTIVENESS
. 1. DEVICE NAME:
Generic Name: Model Name: Trade/ Proprietary Name: Magnetic Resonance Diagnostic Device MRT-1504/U4 Vantage Titan
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
- MANUFACTURING SITE:
Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550 Japan
- DATE OF SUBMISSION:
February 29, 2012
6. DEVICE DESCRIPTION
The new Vantage Titan (Model MRT-1504/U4) MRI System is comparable to the current 1.5T Vantage Titan MRI System. The Vantage Titan uses the same magnet as the current Vantage Titan (K080038). However, the following modifications have been added: a redefinition of gradient strength, magnet cover and cabinet's configuration changes. In addition, two applications software: Diffusion Tensor Tractography (DTT), and PaceMaker.
7. SUMMARY OF MAJOR HARDWARE CHANGES
- a. Gradient Strength (redefinition)
- b. Magnet Cover
- Changes to the cabinet configuration C.
1
8. SUMMARY OF MAJOR SOFTWARE CHANGES
a. Addition of 2 applications software
- i. Diffusion Tensor Tractography (DTT)
ii. PaceMaker (FBI with Auto ECG)
9. SAFETY PARAMETERS
| | New Vantage Titan
(Subject device) | Vantage Titan
(Predicate, K080038) | Vantage Titan HSR
(Predicate, K112003) |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| a. Static field
strength: | 1.5T | 1.5 T | 1.5T |
| b. Peak and A-
weighted acoustic
noise: | 106.2 dB (A-weighed)
115.4 dB(peak) | 105.7dB (A-weighted)
115.7dB (peak) | 113.0 dB (A-weighted)
121.6 dB (peak) |
| c. Operational modes: | 1st operating mode | 1st operating mode | 1st operating mode |
| i. Safety parameter
display: | SAR, dB/dt | SAR, dB/dt | SAR, dB/dt |
| ii. Operating mode
access
requirements: | Allows screen access to
1st level operating mode | Allows screen access to 1st
level operating mode | Allows screen access to
1st level operating mode |
| d. 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)) | 4W/kg for whole body (1st
operating mode specified in
IEC 60601-2-33 (2002)) |
| e. Maximum dB/dt |