(336 days)
No
The document describes a standard MRI system and its technical specifications. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The "Intended Use / Indications for Use" section states that the device is "indicated for use as a diagnostic imaging modality" and its images "yield information that can be useful in diagnosis," not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging modality" and that the images produced "yield information that can be useful in diagnosis."
No
The device description clearly states it is a 3 Tesla Magnetic Resonance Imaging (MRI) System, which is a hardware device. While it mentions a software platform change, the core device is a physical MRI machine.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Vantage Titan 3T is an MRI system. It produces images of the internal structures of the body by using magnetic fields and radio waves. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This is consistent with an imaging device, not an IVD.
- Device Description: The description details the physical components of an MRI machine (magnet, coils, RF system, software), not equipment for analyzing biological samples.
Therefore, the Vantage Titan 3T is a diagnostic imaging device, not an In Vitro Diagnostic device.
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, MOS
Device Description
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan 3T uses 1.6m short and 6.4 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan 3T provides the maximum field of view of 50 x 50 x 45 cm.
The Vantage Titan 3T MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K080038), cleared January 22, 2008 with the following modifications.
- . Field strength of magnet has been changed to 3T.
- . RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in resonance frequency (63MHz -> 123MHz).
- . Number of RF amplifier channels is increased from 1 to 2.
- Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for optional. .
- Software platform has been changed. .
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)
Volunteer studies were conducted to verify imaging performance.
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
Toshiba America Medical Systems, Inc. AUG – 2 2011 Pre-Market Notification 510(k) MRT-3010/A5 Vantage Titan 3T
Attachment 1
510(k) SUMMARY
Magnetic Resonance Diagnostic Device Accessory 1. DEVICE NAME: MRT-3010/A5 Model Name: Trade/Proprietary Name: Vantage Titan 3T
2. ESTABLISHMENT REGISTRATION:
- U.S. Agent Name and Address: Toshiba America Medical Systems, Inc. 3. 2441 Michelle Drive Tustin, Ca 92780
| Contact Person: | Paul Biggins
(714) 730 - 5000 | |
|---------------------|----------------------------------|--|
| Manufacturing Site: | TOSHIBA CORPORATION | |
-
- TOSHIBA CORPORATION lanufacturing Site: MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
- ડ. August 30, 2010 DATE OF SUBMISSION: .
6. DEVICE DESCRIPTION
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan 3T uses 1.6m short and 6.4 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan 3T provides the maximum field of view of 50 x 50 x 45 cm.
The Vantage Titan 3T MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K080038), cleared January 22, 2008 with the following modifications.
- . Field strength of magnet has been changed to 3T.
- . RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in resonance frequency (63MHz -> 123MHz).
- . Number of RF amplifier channels is increased from 1 to 2.
- Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for optional. .
- Software platform has been changed. .
NOTE: The Filed Strength Vantage Titan 3T MRJ System is equivalent to that of the SIEMENS Verio, which is cleared on October 10, 2007 (K072237).
1
Attachment 1
6.1. SUMMARY OF MAJOR HARDWARE CHANGES
- Field strength of magnet has been changed to 3T. a.
- RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in b. resonance frequency (63MHz -> 123MHz).
- Number of RF amplifier channels is increased from 1 to 2. C.
- Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for d. optional.
- Cooling fan box is separated from filter cabinet. e.
- Transformer cabinet has been modified to cover the system power requirement. f.
- Wireless gating is added (optional). g.
SUMMARY OF MAJOR SOFTWARE CHANGES 6.2.
- New RF amplifier cabinet control. a.
- b. New gradient power supply control.
- New Magnet supervisory control. c.
- d. Modified the data base for SAR control for new WB coil.
- Modified the data base for distortion correction and dB/dt calculation for new gradient e. coil.
- f. New software platform.
2
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) MRT-3010/A5 Vantage Titan 3T
K102484
p3/4
7. SAFETY PARAMETERS
Attachment l
| | EXCELART Vantage Titan
(K080038) | New Vantage Titan 3T |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| a. Static field strength: | 1.5 T | 3T |
| b. Peak and A-weighted
acoustic noise: | 105.7dB (A-weighted)
115.7dB (peak) | 111.8 dB (A-weighted)
121.3 dB (peak) |
| c. Operational modes:
i. Safety parameter
display: | 1st operating mode
SAR, dB/dt | Same |
| ii. Operating mode access
requirements: | Allows access to 1st level
operating mode | Same |
| d. Maximum SAR | 4 W/kg for whole body (1st
operating mode specified in IEC
60601-2-33 (2002)) | Same |
| e. Maximum dB/dt |