(86 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard MRI technology and software packages.
No
The device is described as a diagnostic imaging modality that produces images useful in diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Vantage Titan 3T systems are indicated for use "as a diagnostic imaging modality".
No
The device description explicitly states it is a "3 Tesla Magnetic Resonance Imaging (MRI) System," which is a hardware device. The software package mentioned is an addition to this hardware system.
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 outside of the body.
- Device Function: The Vantage Titan 3T system is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structures of the body in vivo (within the living body) using magnetic fields and radio waves.
- Intended Use: The intended use is to produce images for diagnostic purposes by visualizing anatomical structures of the head or body. This is a form of medical imaging, not an in vitro test.
Therefore, the Vantage Titan 3T system falls under the category of medical imaging devices, not in vitro diagnostics.
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 noncontrast 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.
No changes to the previously cleared indication (K102489).
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 (K102489). MRA (MR Angio) software package which functions are same as the MRA package of existing 1.5T MRI Vantage Titan (K080038) is added to Vantage Titan 3T.
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
When interpreted by a 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)
No change from the previous predicate submission (K102489).
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.
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
JAN 1 3 2012
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan 3T, MRT-3010/A5
510(k) SUMMARY AND EFFECTIVENESS
1. DEVICE NAME:
Generic Name: Model Name: Trade/ Proprietary 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
2441 Michelle Drive Tustin, Ca. 92780
Establishment Name and Address:
- MANUFACTURING SITE:
Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550 Japan
Toshiba America Medical Systems, Inc.
October 17, 2011 5. DATE OF SUBMISSION:
6. DEVICE DESCRIPTION:
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System (K102489). MRA (MR Angio) software package which functions are same as the MRA package of existing 1.5T MRI Vantage Titan (K080038) is added to Vantage Titan 3T.
7. SUMMARY OF MAJOR HARDWARE CHANGES Not applicable.
1
8. SUMMARY OF MAJOR SOFTWARE CHANGES
Existing software (V1.20) packages are grouped by functions of softwares and pulse sequences. New software (V1.35) packages are changed the configuration of imaging targets (for example Body package, Breast package etc.). Three software packages which use V1.20 MRA package are added to Vantage Titan 3T.
- a) mCardiovascular package
- b) mBreast package
- c) mBody package
9. SAFETY PARAMETERS
| Item | Vantage Titan 3T with new
application software package
(subject device) | Vantage Titan 3T , K102489
(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 |