(108 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on hardware components and established MRI principles.
No
The device is indicated for use as a diagnostic imaging modality to produce images that aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The MRI system is indicated for use as a diagnostic imaging modality" and that the images "yield information that can be useful in diagnosis."
No
The device description clearly identifies the device as a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, which is a hardware-based medical 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 this is an MRI system. MRI is an imaging modality that produces images of the internal structures of the body using magnetic fields and radio waves. It does not involve testing samples taken from the body.
- Intended Use: The intended use is to produce images for diagnostic purposes, which is a characteristic of imaging devices, not IVDs.
Therefore, this device falls under the category of medical imaging equipment, 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 cross-sectional 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 Vantage Titan with Helios gradient (Model MRT-1504/U5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan with Helios gradient uses the same magnet as the Vantage Titan (K120638). The gradient performance was modified using the same gradient amplifier and gradient coil as Vantage Titan HSR (K112003).
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)
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
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
ATTACHMENT G
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan, v2.1, MRT-1504/U5
510(k) SUMMARY AND EFFECTIVENESS
DEC 1 3:2012
Page 1 of 5
1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
-
- ESTABLISHMENT REGISTRATION: 2020563
CONTACT PERSON AND U.S AGENT INFORMATION:
Charlemagne Chua Contact Person: (714) 730-5000
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
Toshiba America Medical Systems, Inc.
Japan
5. DATE OF SUBMISSION:
-
- DEVICE NAME:
Generic Name: Model Name: Trade/ Proprietary Name: Magnetic Resonance Diagnostic Device MRT-1504/U5 Vantage Titan with Helios gradient
- DEVICE NAME:
August 24, 2012 (Revised 11-5-2012)
7. CLASSIFICATION AND CLASS OF DEVICE
90-LNH, Class II per 21 CFR 892.1000
K122613-S1: Response to Al (10-9-12) Page 33 of 65
1
PREDICATE DEVICE(S):
REASON FOR SUMBISSION 9.
Modification of a cleared device
10. Submission Type Traditional 510(k)
11. DEVICE DESCRIPTION
The Vantage Titan with Helios gradient (Model MRT-1504/U5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan with Helios gradient uses the same magnet as the Vantage Titan (K120638). The gradient performance was modified using. the same gradient amplifier and gradient coil as Vantage Titan HSR (K112003).
12. INTEDED 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.
No changes from the previous submission, K120638
2
Page 3 of 5
13. SUMMARY OF MAJOR HARDWARE CHANGES
- Gradient Amplifier
- Gradient Coil : b.
14. SUMMARY OF MAJOR SOFTWARE CHANGES
- a. There are no software changes.
15. SUMMARY OF IMPROVEMENTS
- MRS Scan a.
- b. Altibase (Database SW), version upgrade
... ...
- c. . Scan parameter window -----
- ರ. Reconstruction speed
- e. Locator window operation
- Clinical application operability f.
- Autoview GUI g.
- Automatic map-scan h.
- Implementation of 3D Advanced Fourier Imaging (AFI) i.
- New coils (cardiac, Head, Spine and Flexible SPEEDER) i:
: : :
K122613-S1: Response to AI (10-9-12) Page 35 of 65
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Toshiba America Medical Systems, Inc.
Pre-Market Notification 510(k) Vantage Titan, v2.1, MRT-1504/U5
16. SAFETY PARAMETERS
| | Vantage Titan with
Helios gradient
(Subject device) | Vantage Titan
(K120638) | Vantage Titan HSR
(K112003) |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| a. Static field
strength: | 1.5T | 1.5T | 1.5T |
| b. Peak and A-
weighted acoustic
noise: | 112.0 dB (A-weighed)
122.9 dB(peak) | 106.2 dB (A-weighted)
115.4 dB (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 |