(88 days)
No
The summary describes software and hardware upgrades for an existing MRI system, focusing on new sequences and increased slice capabilities. There is no mention of AI, ML, or related concepts, nor any description of training or test sets typically associated with AI/ML development.
No
The device is described as an upgrade for an MRI system, intended for diagnostic imaging (2D/3D Imaging, MR Angiography) and exciting hydrogen nuclei, which are functions of an imaging device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic Use: 2D/3D Imaging, MR Angiography".
No
The device description explicitly states that Version 12.1 adds new hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states the device is a software upgrade for an MRT (Magnetic Resonance Tomography) system, which is used for imaging the human body directly.
- The intended use is diagnostic imaging. While diagnostic, this is achieved through non-invasive imaging of the patient, not by analyzing biological samples.
- There is no mention of analyzing biological samples or specimens. The focus is on acquiring and processing MR images.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart
Nuclei excited: Hydrogen
Diagnostic Use: 2D/3D Imaging, MR Angiography
Product codes
Not Found
Device Description
The Software Version 12.0/12.1 Upgrade for the MRT-50A/MRT-150A adds new sequences and software enhancements to the existing MRT-50A/150A software version. Version 12.1 also adds a new hardware to increase the number of slices available for FastSE sequences.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, Body, Extremity, Spine, Neck, TMJ, and Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Sample phantom images and clinical images were presented for all new sequences. Signal-to-noise ratios for each phantom image were given. Clinical studies were presented for all new sequences.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
TOSHIBA
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TOSHIBA AMERICA MRI, INC.
280 UTAH AVENUE. SOUTH SAN FRANCISCO. CA 94080 PHONE: (415) 872-2722
IN 2 8 1006
510(k) Summary
SUMMARY OF SAFETY AND EFFECTIVENESS MRT-50A/150A SOFTWARE UPGRADE 12,0 and MRT-150A SOFTWARE UPGRADE 12,1
-
- Model Name: MRT-50A/MRT-150A Magnetic Resonance Device Accessory Device Name: MRT-50A/150A Upgrade 12.0, MRT-150A Upgrade 12.1 Trade/Proprietary Name:
- #2936923 2. Establishment Registration:
- TOSHIBA AMERICA MRI, INC. 3. Name and Address: 280 Utah Avenue South San Francisco, CA 94080
- Contact Person: Steven M. Kay (714) 730-5000
- DATE OF SUBMISSION: 4. March 27, 1996
DEVICE DESCRIPTION 5.
The Software Version 12.0/12.1 Upgrade for the MRT-50A/MRT-150A adds new sequences and software enhancements to the existing MRT-50A/150A software version. Version 12.1 also adds a new hardware to increase the number of slices available for FastSE sequences.
DEVICE CHARACTERISTICS: 6.
The V12.0/12.1 product is an upgrade to the MRT-50A/150A software release V11.9. V12.0/12.1 includes hardware upgrades, software changes and new sequences. The hardware upgrade in V12.1 increases the number of slices available for FastSE sequences. Version 12.0 software changes provide improved FastSE sequences and Multislab MRA. Version 12.1 software changes provide improved Fat Suppression sequences and STC Imaging.
SAFETY PARAMETERS 7.
| MRT-50A | MRT-150A | |
|---|---|---|
| Maximum static field strength: | 0.5T | 1.5T |
| There are no changes to B0 | ||
| Rate of change of magnetic field: | 7.5T/sec, $\tau$ = 1000ms | 7.5T/sec, $\tau$ = 1000ms |
| There are no changes to dB/dt | ||
| Radio frequency power deposition: | 0.3W/kg max SAR | 0.8W/kg max SAR |
| S.A.R. remains below the cleared levels. | ||
| Acoustic Noise levels: | 80 dB | 105 dB worst case |
| 85 - 100 dB typical |
Acoustic noise data was measured in accordance with NEMA guidelines.
1
510(k) Summary (cont'd)
SUMMARY OF SAFETY AND EFFECTIVENESS MRT-50A/160A SOFTWARE UPGRADE 12,0 and MRT-150A SOFTWARE UPGRADE 12,1
8. IMAGING PERFORMANCE PARAMETERS
| MRT-50A | MRT-150A | |
|---|---|---|
| Specification volume: | Head: 14cmX14cmX14cm | |
| Body: 125mm diameter cross section X 250mm long | 10cm dsv | |
| 20cm dsv | ||
| Signal to noise ratio: | Sample phantom images and clinical images were presented for all new sequences. Signal-to-noise ratios for each phantom image were given. Clinical studies were presented for all new sequences. | |
| Uniformity in three orthogonal planes: | Unchanged | |
| Slice Profile in three orthogonal planes: | Unchanged | |
| Geometric Distortion in three orthogonal planes: | Unchanged | |
| V12.0 and V12.1 do not change the gradient system, especially with regard to linearity. | ||
| It is the gradient linearity that affects geometric distortion. | ||
| Slice Thickness: | Not Applicable | |
| Interlice Snaring. | Not Annlinghle |
9. INTENDED USE
: 1
| Anatomical Region: | Head, Body, Extremity, Spine, Neck, TMJ, and Heart |
|---|---|
| Nuclei excited: | Hydrogen |
| Diagnostic Use: | 2D/3D Imaging, MR Angiography |
10. EQUIVALENCY INFORMATION
Version 12.0/12.1 Upgrade for the MRT-50A/150A is substantially equivalent to the V11.9 Software release for the MRT-50A/150A. The 510(k) submission for V11.9 received FDA clearance on January 26, 1995 (K941864). Some of the scanning techniques require that the Super Performance Package be installed on the MRI system. Version 11.1 with the Super Performance Package was cleared for the MRT-50A in K924808. Version 11.1 was cleared for the MRT-150A in K914012. The MRT-150A with the Super Performance Package received market clearance in K925286.
Version 12.0/12.1 provides an improved selection of FastSE sequences, adds the FastIR technique and improves the performance of the Vascular Imaging Package. All safety and effectiveness attributes remain essentially unchanged.