(96 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the new software functionalities does not mention any AI/ML techniques.
No
The device is described as a diagnostic imaging modality that produces images for diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section states: "Vantaqe Titan 3T systems are indicated for use as a diagnostic imaging modality..." and "...When interpreted by a trained physician, these images yield information that can be useful in diagnosis."
No
The device description explicitly states it is a "3 Tesla Magnetic Resonance Imaging (MRI) System" and lists software functionalities added to this existing hardware system. It is not solely software.
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 Vantage Titan 3T system is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structures of the body using magnetic fields and radio waves. This is an in vivo imaging modality, meaning it examines the body directly, not samples taken from the body.
- Intended Use: The intended use clearly states it produces images of anatomical structures of the head or body for diagnostic imaging. This aligns with the function of an MRI, not an IVD.
Therefore, the Vantage Titan 3T system is a diagnostic imaging device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Vantage Titan 3T 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 (comma separated list FDA assigned to the subject device)
LNH
Device Description
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K120487. This submission will include the following five software functionalities: Changes in the SAR calculation method, 3D ASL (3 dimensional Arterial Spin Labeling), Advanced Moving Bed (AMB), 3D MRS (3 dimensional MR Spectroscopy) and Distortion correction for entire volume are added to Vantage Titan 3T.
Mentions image processing
Yes
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Toshiba America Medical Systems, Pre-Market Notification 510(k) Vantage Titan 3T, MRT-3010/A5
510(k) SUMMARY AND EFFECTIVENESS
1. CLASSIFICATION and DEVICE NAME:
| Classification Name: | Magnetic Resonance Diagnostic Device |
|---|---|
| Regulation Number: | 21 CFR 892.1000 |
| Product Code: | LNH |
| Trade Proprietary Name: | Vantage Titan 3T |
| Model Number: | MRT-3010/A5 |
2. ESTABLISHMENT REGISTRATION: 2020563
3. CONTACT PERSON, U.S AGENT and ADDRESS:
Contact Person Charlemagne Chua Manager, Regulatory Affairs (714) 669-7896
OCT 16 2013
U.S. Agent Name: Paul Biggins Director, Regulatory Affairs (714) 730-5000
Establishment Name and Address:
Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780
4. MANUFACTURING SITE:
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
5. DATE OF SUBMISSION:
July 10, 2013
6. DEVICE DESCRIPTION:
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K120487. This submission will include the following
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five software functionalities: Changes in the SAR calculation method, 3D ASL (3 dimensional Arterial Spin Labeling), Advanced Moving Bed (AMB), 3D MRS (3 dimensional MR Spectroscopy) and Distortion correction for entire volume are added to Vantage Titan 3T.
7. SUMMARY OF HARDWARE CHANGES
There are no major hardware changes associated with the software change.
8. SUMMARY OF SOFTWARE CHANGES
Existing software packages are grouped by functions of software and pulse sequences. New software (V2.30) packages (four software functionalities) as follows:
a) Changes in the SAR calculation method
The new calculation method provides more flexibility in setting scan parameters, which enables scan with increased number of slices per unit time etc.
b) 3D ASL (3 dimensional Arterial Spin Labeling)
This function of software adds a new feature for current ASL imaging so that images can be acquired from 3D volume instead of 2D slice.
c) Advanced Moving Bed (AMB)
AMB enables individual scan settings for each station when Moving Bed is used. It allows acquisition of images with the most appropriate settings for each station.
d) 3D MRS (3 dimensional MR Spectroscopy)
This function of software enables the acquisition of proton spectroscopic data from multiple voxel in a 3 dimensional volume of an object by applying phase encode aradients in three orthogonal directions.
e) Distortion correction for entire volume
This function of software performs correction of image distortion due to gradient magnetic field non-linearity for entire 3D volume including slice direction.
9. SAFETY PARAMETERS
| Item | Vantage Titan 3T with
new application software
package
(subject device) | Vantage Titan 3T ,
K120487
(Predicate Device) | Notes |
|-----------------------|----------------------------------------------------------------------------------|-----------------------------------------------------|-------|
| Static field strength | 3T | 3T | Same |
| Operational Modes | 1st Operating Mode | 1st Operating Mode | Same |
2
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan 3T, MRT-3010/A5
| 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 |