(81 days)
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Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its enhancements do not mention any AI/ML capabilities.
No.
The device is described as an upgrade for a Magnetic Resonance (MR) system, with its primary function being 2D and 3D imaging for diagnostic use, rather than treating a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic Use: 2D and 3D imaging, Contrast Media, MR Vascular Imaging."
No
The device is described as an "Upgrade for MRT-35A," which is an existing system. The upgrade adds a "new sequence and software enhancements." While it includes software, the description implies it is an upgrade to a hardware system (MRT-35A, likely an MRI machine), not a standalone software device. The performance studies also mention phantom and clinical images, which are generated by the underlying hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for imaging (2D and 3D imaging, Contrast Media, MR Vascular Imaging) of various anatomical regions using Magnetic Resonance. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Device Description: The description focuses on software enhancements for an existing Magnetic Resonance system (MRT-35A).
- Input Imaging Modality: The input is Magnetic Resonance, which is an imaging technique, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
In summary, this device is clearly described as a software upgrade for a Magnetic Resonance imaging system, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The 8.5CD Upgrade for MRT-35A adds a new sequence and software enhancements to the existing MRT-35A software version.
Mentions image processing
Pre and Post Processing: No baseline correction except for data conjugation of Advanced Fourier Imaging, Post processing filtering
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, body, extremity, spine, neck, TMJ, Knee
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sample phantom images and clinical images were presented for all new sequences. Signal-to-noise ratios for each phantom image was given. Clinical studies were presented for all new sequences.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
APPENDIX A
510(k) SUMMARY
AUG - 2 1996
1
510(k) Summary
| 1. | Model Name:
Device Name:
Trade/Proprietary Name: | MRT-35A
Magnetic Resonance Device Accessory
MRT-35A Upgrade 8.5CD |
|----|--------------------------------------------------------|-------------------------------------------------------------------------------|
| 2. | Establishment Registration: | #2936923 |
| 3. | Name and Address: | TOSHIBA AMERICA MRI, INC.
280 Utah Avenue
South San Francisco, CA 94080 |
| | Contact Person: | Steven M. Kay
(714) 730-5000 |
| 4. | DATE OF SUBMISSION: | 26 April 1996 |
DEVICE DESCRIPTION 5.
The 8.5CD Upgrade for MRT-35A adds a new sequence and software enhancements to the existing MRT-35A software version.
5A. DEVICE CHARACTERISTICS:
The following describes the MRT-35A system with the 8.5CD Upgrade.
| Type of magnet | Superconductive |
|---|---|
| Static Field | 0.35 Tesla |
| Type of RF Coil | Not applicable |
| Data Acquisition Mode | 2D Multislice, Multiecho, 3DFT |
| Pulse sequences | Spin echo, Inversion recovery, Fast spin echo, Cardiac |
| Gated, Partial Flip, Matched Bandwidth, 3D, inplane | |
| presaturation, Spectre, Angiography, 2D Time-of-Flight | |
| Reconstruction Technique | 2 Dimensional Fourier |
| 3 Dimensional Fourier | |
| 3 Dimensional Slice shift, | |
| Oblique, MIP for Angio | |
| Display Matrix: | 512x512 |
| Slice Selection method: | Selective gradient, "slab" select slice encode for 3D |
| Acquisition Matrix: | 256x32 to 256x256 in steps of 1 |
| Image Acquisition Time: | 3 seconds for fluoro acquisitions typical, 6 minutes for 4 |
| NEX FSE typical | |
| Pre and Post Processing: | No baseline correction except for data conjugation of |
| Advanced Fourier Imaging, Post processing filtering | |
| Number of slices: | 64 for 3D acquisitions, protocol file limit of 256 slices |
| Slice Orientation: | unrestricted |
| Spacing: | gapless imaging |
2
New Hardware and Hardware Changes 5A.1
Version 8.5CD does not change the configuration of hardware for the MRT-35A.
5A.2 New Software Features
Version 8.5CD does not introduce new software features to the MRT-35A.
5A.3 New Sequences and Sequence Changes
2D Time of Flight(TOF) sequence 5A.3.1
The 8.5CD upgrade provides a 2DTOF sequence. 2DTOF includes optional walking presat (superior or inferior) to reduce the signal from adjacent tissue due to motion. The user interface for sequence selection and parameter specification common to other sequences is supported for 2DTOF also. There is no exceptional change in the manner that 2DTOF is selected when compared to pre-existing sequences. Acquisition orientation is restricted to transaxial orientation only. The sequence will not support oblique orientations nor gated acquisitions.
5A.3.2 Sequence specification summary
The new 2DTOF sequence, with its identification parameters, is given below. With the exception of this additional sequence, there is no change to the sequence software.
| Seq # | Sequence
Type | TE | Flow
Comp | Min Thick
8.5CD | Difference
from 8.0CD |
|-------|------------------|----|--------------|--------------------|--------------------------|
| 27 | 2D ANGIO
TOF | 12 | FC | 2.0mm | NEW |
SAFETY PARAMETERS 6.
| Maximum static field strength: | 0.35 Tesla |
|---|---|
| Rate of change of magnetic field: | 6.83 Tesla/sec Axial |
| 6.69 Tesla/sec Transverse | |
| Radio frequency power deposition: | 0.34 W/kg |
| Acoustic Noise levels: | L-peak: 101.6 db (peak impulse sound |
| pressure) | |
| L-eq: 86.5 db (time integral of a-weighted | |
| sound pressure) |
3
7. IMAGING PERFORMANCE PARAMETERS
| Specification volume | 10 Cm dsv for head coil
20 Cm dsv for body coil |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Signal to noise: | Sample phantom images and clinical images were
presented for all new sequences. Signal-to-noise
ratios for each phantom image was given. Clinical
studies were presented for all new sequences. |
| Uniformity in three orthogonal planes | Not Applicable |
| Slice Profile in three orthogonal planes | Not Applicable |
| Geometric Distortion in three
orthogonal planes | Not Applicable |
| Slice Thickness | 0.8 mm to limits of FOV and sequence. |
| Interslice Spacing | 0 mm minimum |
8. Intended Use
1
| Anatomical Region: | Head, body, extremity, spine, neck, TMJ, Knee |
|---|---|
| Nuclei excited: | Hydrogen |
| Diagnostic Use: | 2D and 3D imaging, Contrast Media, MR Vascular |
| Imaging |
Equivalency Information 9.
8.5CD Upgrade for MRT-35 is substantially equivalent to the 8.0CD Software release for MRT-35. Similarity and/or differences between this device and the predicate device are summarized below.
HARDWARE ENHANCEMENTS
8.5CD has no hardware component differences from the preceding MRT-35A upgrade, 8.0CD.
SOFTWARE ENHANCEMENTS
| Technical | Clinical |
|---|---|
| Improved Image Reconstruction for FSE | |
| Image reconstruction software is provided to | |
| further reduce subtle acquisition artifacts | |
| previously found in TE=20 Fast Spin Echo (FSE) | |
| sequences. | Image quality is improved for Fast Spin |
| Echo TE=20 (4 and 7 echo). |
SEQUENCE ENHANCEMENTS
| Technical | Clinical |
|---|---|
| 2D Time-Of-Flight (TOF) Sequence | |
| A new 2DTOF sequence is provided with optional | |
| pre-saturation bands that are user selected. | Allows image acquisitions of vascular |
| structures with reduced motion artifacts. |