(96 days)
Not Found
Unknown
The summary mentions "Image filter EM AIDR" as a software package, which could potentially utilize AI/ML for image processing or reconstruction. However, the summary does not explicitly state that AI or ML is used, nor does it provide details about training or test sets, which are common indicators of AI/ML implementation in medical devices. Without further information, it's impossible to definitively confirm the presence of AI/ML.
No
The intended use statement explicitly states that the device is "indicated for use as a diagnostic imaging modality". It also mentions that the images "can be useful in diagnosis," not treatment.
Yes
The "Intended Use / Indications for Use" states that the system is a "diagnostic imaging modality" and the images "yield information that can be useful in diagnosis."
No
The device is described as a 3 Tesla Magnetic Resonance Imaging (MRI) System, which is a hardware device. While it includes software packages, the core device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is a "diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This describes an in vivo imaging system, not a device that performs tests on samples taken from the body (in vitro).
- Device Description: The device is described as a "3 Tesla Magnetic Resonance Imaging (MRI) System." MRI is an in vivo imaging technique.
- Input Imaging Modality: The input modality is Magnetic Resonance Imaging (MRI), which is an in vivo imaging technique.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates by imaging the body directly.
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 vield 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(K113093). Four software packages (Positioning Assist for Cardiac, Diffusion Tensor Tractography (DTT) , Cardiac Function Analysis, and Image filter EM AIDR are added to Vantage Titan 3T.
Existing software (V1.35) packages are grouped by functions of software and pulse sequences. New software (V2.0) packages are added four application software as follows:
a) Positioning Assist for Cardiac This function of software assists the operator to position for scanning for Cardiac imaging for easy operation. The operator shall confirm the patient position before starting the cardiac scanning and the operator can re-adjust the scanning position if needed.
b) Diffusion Tensor Tractography (DTT)
i. DTT represents direction of the central nerves by using anisotropy of diffusion coefficients calculated from the DTI map.
ii. The central nerves are represented as bundle fibers in 3D volume.
iii. DTT can visualize the fusion of SVR with cut-off plan. DTI maps and bundle of fibers in 3D view.
a. SVR- is reconstructed Surface Volume Rendering image from anatomical images.
iv. DTT can also visualize the fusion of cross sections, DTI maps and bundle of fibers
c) Cardiac Function Analysis
This function of software makes cardiac cine image and visual evaluation of wall motion abnormality. This function shows the graphs and tables of the result of cardiac function analysis like Bull's eye map of wall thickening.
d) Image filter EM AIDR
This is an image filter which can reduce the ringing artifact especially in low resolution images.
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 Vantage Titan 3T, v2.0, MRT-3010/A
510(k) SUMMARY AND EFFECTIVENESS
-
- DEVICE NAME:
Generic Name: Model Name: Trade/ Proprietary Name:
- DEVICE NAME:
Magnetic Resonance Diagnostic Device MRT-3010/A5 . Vantage Titan 3T
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: | February 16, 2012 |
6. DEVICE DESCRIPTION:
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System(K113093). Four software packages (Positioning Assist for Cardiac, Diffusion Tensor Tractography (DTT) , Cardiac Function Analysis, and Image filter EM AIDR are added to Vantage Titan 3T.
6. SUMMARY OF MAJOR HARDWARE CHANGES Not applicable.
7. SUMMARY OF MAJOR SOFTWARE CHANGES
Existing software (V1.35) packages are grouped by functions of software and pulse sequences. New software (V2.0) packages are added four application software as follows:
- a) Positioning Assist for Cardiac This function of software assists the operator to position for scanning for Cardiac imaging for easy operation. The operator shall confirm the patient position before
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1
starting the cardiac scanning and the operator can re-adjust the scanning position if needed.
- b) Diffusion Tensor Tractography (DTT)
- i. DTT represents direction of the central nerves by using anisotropy of diffusion coefficients calculated from the DTI map.
- ii. The central nerves are represented as bundle fibers in 3D volume.
- iii. DTT can visualize the fusion of SVR with cut-off plan. DTI maps and bundle of fibers in 3D view.
- a. SVR- is reconstructed Surface Volume Rendering image from anatomical images.
- iv. DTT can also visualize the fusion of cross sections, DTI maps and bundle of fibers
- c) Cardiac Function Analysis
This function of software makes cardiac cine image and visual evaluation of wall motion abnormality. This function shows the graphs and tables of the result of cardiac function analysis like Bull's eye map of wall thickening.
- d) Image filter EM AIDR
This is an image filter which can reduce the ringing artifact especially in low resolution images.
2
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan 3T, v2.0, MRT-3010/A5
8. SAFETY PARAMETERS
| Item | Vantage Titan 3T
(subject device) | Vantage Titan 3T
K113093
(Predicate Device) | Notes |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------|
| Static field strength | 3T | 3T | 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 |